In-vivo visualization system

ABSTRACT

Several embodiments of the present invention are generally directed to medical visualization systems that comprise combinations of disposable and resuable components, such as catheters, functional handles, hubs, optical devices, etc. Other embodiments of the present invention are generally directed to features and aspects of an in-vivo visualization system that comprises an endoscope having a working channel through which a catheter having viewing capabilities is routed. the catheter may obtain viewing capabilities by being constructed as a vision catheter or by having a fiberscope or other viewing device selectively routed through one of its channels. The catheter is preferably of the steerable type so that the distal end of the catheter may be steered from its proximal end as it is advanced with the body. A suitable use for the in-vivo visualization system includes but is not limited to diagnosis and/or treatment of the duodenum, and particularly the biliary tree.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation-in-part of prior U.S. applicationSer. No. 10/914,411, filed Aug. 9, 2004. This application also claimsthe benefit of U.S. Provisional Application No. 60/555,356, filed Mar.23, 2004, and U.S. Provisional Application No. 60/656,801, filed Feb.25, 2005. All of the aforementioned applications are hereby incorporatedby reference.

FIELD OF THE INVENTION

Embodiments of the present invention generally relate to medicaldevices. Several embodiments are generally directed to medical catheterswith steering and/or optical capabilities. Other embodiments aregenerally related to medical systems, such as in-vivo visualizationsystems, that are suitable for viewing and/or performing diagnostic andtherapeutic modalities within the human body, such as in the biliarytree.

BACKGROUND OF THE INVENTION

A challenge in the exploration and treatment of internal areas of thehuman anatomy has been adequately visualizing the area of concern.Visualization can be especially troublesome in minimally invasiveprocedures in which small diameter, elongate instruments, such ascatheters or endoscopes, are navigated through natural passageways of apatient to an area of concern either in the passageway or in an organreachable through the passageway.

Ureteroscopy is one form of procedure that is performed to diagnosis andtreat urinary tract diseases and ureteral strictures. In conventionalureterscopy, a ureteroscope is inserted retrograde through the urinarytract such that diagnosis and treatment of urinary tract abnormalitiesoccur under direct visualization. Ureteroscopes are typically 7-10Fr. indiameter and include a sheath that encapsulates a fiber optic element,an illumination element and a working channel. The working channelallows for the passage of working devices, such as guidewires, stoneretrieval baskets and lasers. Some ureteroscopes also incorporate asteering mechanism, which allows the distal tip of the scope to bedeflected by the user in one or more planes. Steering is typicallyachieved via manipulation at the handle end of the scope, ex-vivo.

Problems, however, exist in the use of prior art ureteroscopes. Forexample, after each successive urological procedure, the scope must becleaned and sterilized before the next use, which delays successiveprocedures unless multiple scopes are purchased. Furthermore, currentureteroscopes are non-disposable and require extensive, expensivemaintenance. Sterilization delays and costs associated with purchasingand/or repairing scopes have escalated costs for ureteroscopicprocedures and other medical procedures that utilize similarlyconfigured scopes.

Detailed information regarding other parts of the anatomy can bediscerned from direct viewing of the anatomy provided through one ormore of the elongate instruments used in other various medicalprocedures, such as colonoscopy, upper endoscopy, bronchoscopy,thoracoscopy, laparoscopy, and hysteroscopy. For use in theseprocedures, various types of endoscopes configured for use in variouspassageways of the body, such as the esophagus, rectum or bronchus, canbe equipped with direct viewing capability through the use of opticalfibers extending through the length of the scope, or with digitalsensors, such as CCD or CMOS. However, because endoscopes also provide aworking channel through which other medical instruments must pass,optional lighting bundles and components to provide steering capabilityat its distal end, the scope is typically of a relatively largediameter, e.g., 5 mm or greater. This large diameter limits the use ofthe endoscope to relatively large body lumens and prohibits their use insmaller ducts and organs that branch from a large body lumen, such asthe biliary tree.

Typically when examining small passageway such as the bile duct orpancreatic duct, the endoscope is used to get close to a smallerpassageway or region of concern and another instrument, such as acatheter, is then extended through the working channel of the endoscopeand into the smaller passageway. Although the endoscope provides directvisualization of the large body passageway and entrance to adjoiningducts and lumens, after the smaller catheter has been extended from theendoscope into the smaller duct or lumen, direct visualization hasheretofore been limited, and the physician usually relies onradiographical means to visualize the area of concern or probes blindly.

SUMMARY OF THE INVENTION

In accordance with aspects of the present invention, a medicalvisualization system is provided. The system includes an endoscopehaving an endoscope insertion tube extending distally from an endoscopehandle. The endoscope handle has an access port for accessing aninterior lumen of the insertion tube. The endoscope includes an imagingdevice for viewing objects located at the distal end of the insertiontube. The system also includes a catheter assembly comprising a catheterextending distally from a catheter handle. The catheter handle isselectively mounted to the endoscope and has an access port foraccessing an interior lumen of the catheter, wherein the catheter may beinserted into the endoscope access port and routed through a portion ofthe insertion tube interior lumen. The system further includes anoptical assembly comprising an image transmission cable having distaland proximal ends, wherein the image transmission cable is configuredfor insertion into the catheter access port and routable through aportion of the catheter interior lumen. The optical assembly is capableof obtaining images located at the distal end of the catheter andtransmitting the images to the proximal end of the cable.

In accordance with another aspect of the present invention, a medicalvisualization system is provided. The system includes a disposablecatheter having a proximal end and a distal end. The catheter definesone or more interior lumens that extend from the distal end to theproximal end. The system further includes a control handle including anactuation device that effects distal end catheter deflection. Thecontrol handle is functionally connected to the proximal end of thecatheter. The system further includes a reusable optical assembly thatincludes an optical handle and an optical cable extending therefrom. Theoptical cable is routable through a portion of the interior catheterlumen from a position exterior to the catheter.

In accordance with another aspect of the present invention, a catheterhandle is provided. The catheter handle is suitable for steering acatheter shaft having a proximal region and a distal region and at leastone steering wire having a distal end region secured at or near thedistal end region of the catheter shaft and a proximal end. The catheterhandle includes a catheter housing having the proximal end of thecatheter shaft attached thereto and a steering controller carried by thecatheter housing and having the proximal end of the at least onesteering wire connected thereto. The steering controller is movable froma first position to a second position. The steering controller iscapable of applying tension to the at least one steering wire when thesteering controller moves from the first position to the secondposition. The catheter handle further includes a lock mechanism forretaining the steering controller in the second position to preventmovement thereof. The lock mechanism includes a lever movable between anunlocked position and a locked position. The lever is associated withthe steering controller such that movement of the lever to the lockedposition restricts movement of the steering controller.

In accordance with aspects of the present invention, a method ofbifurcating the interior lumens of a catheter for connection to one ormore fittings is provided. The method includes obtaining a connectorhaving a central passageway and first and second branch passagewayconnected thereto, obtaining a catheter having first and second interiorlumens extending longitudinally therethrough, and forming first andsecond openings in the outer surface of the catheter at selected, spacedlocations for accessing the first and second interior lumens. Thelocation of the first and second openings correspond to theintersections of the first and second branch passageways with the centerpassageway of the connector, respectively. The method further includesrouting the catheter into the central passageway until the first andsecond openings communicate with the first and second branchpassageways, respectively.

In accordance with another aspect of the present invention, a method ofexamining a patient in-vivo is provided. The method includes providingan endoscope with an insertion tube having at least one channel. Theendoscope has viewing capabilities at the distal end of the insertiontube. The method also includes providing a catheter having at least onechannel, providing an imaging device having an image transmission cable,and advancing the insertion tube into a passageway of a patient underdirect visualization by the insertion tube. The method further includesadvancing the catheter through the insertion tube to a position at ornear the distal end of the insertion tube; and advancing the imagetransmission cable through the catheter channel to a position at of nearthe distal end of the catheter.

In accordance with another aspect of the present invention, a method isprovided for cannulating the papilla of a patient. The method includesproviding an optical device having viewing capabilities, providing anendoscope with viewing capabilities and at least one channel, andproviding a catheter having at least one channel. The method alsoincludes placing the distal end of the endoscope into the duodenum of apatient and adjacent to the papilla and inserting the catheter into thechannel of the endoscope and routing the catheter to the distal end ofthe endoscope. The method further includes advancing the optical devicethrough the catheter channel to the distal end of the catheter; andadvancing the catheter and optical device from the endoscope and throughthe papilla under visual inspection of the endoscope.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing aspects and many of the attendant advantages of thisinvention will become more readily appreciated by reference to thefollowing detailed description, when taken in conjunction with theaccompanying drawings, wherein:

FIG. 1 is an assembly view of an optical catheter system according toone embodiment of the invention;

FIG. 2 is a perspective end view of the distal tip of the catheterillustrated in FIG. 1;

FIG. 3 is perspective end view of the distal tip of the catheterillustrated in FIG. 1, where the sheath of the catheter has been removedto expose the elongated, internal body of the catheter;

FIG. 4 is a cross-sectional view of the elongated body of the catheterillustrated in FIG. 3, taken along the line 4-4 in FIG. 3;

FIG. 5 is a cross-sectional view of an alternative embodiment of acatheter of the system illustrated in FIG. 1, where the cross-section istaken along a longitudinal axis of the catheter;

FIG. 6 is an assembly view of an optical catheter system according toanother embodiment of the invention;

FIG. 7 is an assembly view of an optical catheter system according to afurther embodiment of the invention;

FIG. 8 is a perspective view of one embodiment of a handle of theoptical catheter system illustrated in FIG. 7;

FIG. 9 is an assembly view of an optical catheter system according toanother embodiment of the invention;

FIG. 10 is an assembly view of an optical catheter system according to afurther embodiment of the invention;

FIG. 11 is an assembly view of an optical catheter system according toan additional embodiment of the invention;

FIG. 12A is a partial longitudinal cross section view of anotherembodiment of a catheter formed in accordance with aspects of thepresent invention;

FIG. 12B is a partial longitudinal cross section view of anotherembodiment of a catheter formed in accordance with aspects of thepresent invention;

FIG. 13A is a partial longitudinal cross section view of anotherembodiment of a catheter formed in accordance with aspects of thepresent invention;

FIG. 13B is a partial longitudinal cross section view of anotherembodiment of a catheter formed in accordance with aspects of thepresent invention;

FIG. 14A is a partial view of one suitable embodiment of a catheter bodyconstructed in accordance with aspects of the present invention;

FIG. 14B is a partial view of one suitable embodiment of a catheterformed by taking the catheter body of FIG. 14A and encasing saidcatheter body with a reinforcement sheath;

FIG. 14C is a partial view of one suitable embodiment of a catheterformed by taking the catheter of FIG. 14B and encasing said catheterwith an outer sleeve;

FIG. 15 is a cross sectional view of the catheter taken along lines 9-9in FIG. 14B;

FIG. 16 is a partial view of the distal end of another embodiment of acatheter that is suitable for used in the system illustrated in FIG. 1;

FIG. 17 is a partial view of the distal end of another embodiment of acatheter that is suitable for used in the system illustrated in FIG. 1;

FIG. 18 is a partial view of the distal end of another embodiment of acatheter that is suitable for used in the system illustrated in FIG. 1;

FIG. 19A is a perspective view of one suitable embodiment of a catheterassembly suitable for use in an optical catheter assembly;

FIG. 19B is a top view of the catheter assembly shown in FIG. 19A;

FIG. 19C is a perspective cross section view of the catheter assemblyshown in FIG. 19A;

FIG. 19D is a top cross section view of the catheter assembly shown inFIG. 19A;

FIG. 20 is a planar view of one suitable embodiment of an opticalassembly suitable for use in an optical catheter assembly;

FIG. 21 is a partial bottom view of the catheter assembly shown in FIG.19A

FIG. 22 is a cross sectional view of the imaging device cable of FIG. 20

FIG. 23A is a side view of the optical handle of FIG. 20;

FIG. 23B is a side view of the optical handle of FIG. 20 showing thedetachable nature of its components;

FIG. 24 is a perspective view of another catheter handle formed inaccordance with aspects of the present invention;

FIG. 25 is a top view of another catheter handle formed in accordancewith aspects of the present invention;

FIG. 26 is a top view of another catheter handle formed in accordancewith aspects of the present invention;

FIGS. 27A-27B are partial perspective views of a distal portion of oneembodiment of a catheter formed in accordance with aspects of thepresent invention, several portions of FIG. 27 is shown incross-section;

FIG. 28 is a perspective view of one embodiment of a catheter distal endcap formed in accordance with aspects of the present invention;

FIG. 29 is a perspective view of another suitable embodiment of acatheter assembly suitable for use in an optical catheter assembly;

FIG. 30 is a cross-sectional view of another embodiment of a catheterthat is suitable for use with the catheter assembly shown in FIG. 19A;

FIG. 31 is a front elevational view of one representative embodiment ofan in-vivo visualization system constructed in accordance with aspectsof the present invention;

FIG. 32 is a lateral cross sectional view of an insertion tube of anendoscope shown in FIG. 31;

FIG. 33 is a perspective view of one embodiment of a catheter assemblyconstructed in accordance with aspects of the present invention;

FIG. 34 is a perspective view of the catheter assembly shown in FIG. 33with one housing half removed;

FIGS. 35A-35C are cross sectional views of suitable embodiments of acatheter constructed in accordance with aspects of the presentinvention;

FIG. 36A is a partial view of one suitable embodiment of a catheter bodyconstructed in accordance with aspects of the present invention;

FIG. 36B is a partial view of one suitable embodiment of a catheterformed by taking the catheter body of FIG. 36A and encasing saidcatheter body with a reinforcement sheath;

FIG. 36C is a partial view of one suitable embodiment of a catheterformed by taking the catheter of FIG. 36B and encasing said catheterwith an outer sleeve;

FIG. 37 is a cross sectional view of the catheter taken along lines39-39 in FIG. 38B;

FIGS. 38A-38C are cross sectional views of suitable embodiments of acatheter constructed in accordance with aspects of the presentinvention;

FIGS. 39A-39C are cross sectional views of suitable embodiments of acatheter constructed in accordance with aspects of the presentinvention;

FIG. 40 is a partial perspective view of a catheter handle with thecontrol knobs removed to illustrate a lock lever;

FIG. 41 is a partial cross sectional view of a catheter handle showing asuitable embodiment of an irrigation port connected to irrigation lumensof the catheter;

FIG. 42 is a partial cross section view of the catheter handle showingthe steering mechanism and the optional locking mechanism;

FIG. 43A is a front exploded perspective view of components of thelocking mechanism of FIG. 42;

FIG. 43B is a rear exploded perspective view of components of thelocking mechanism of FIG. 42;

FIG. 44 is a partial perspective view of the catheter handle of FIG. 41illustrating a suitable embodiment of an endoscope attachment device;

FIG. 45 is a cross sectional view of one embodiment of a Y connectorformed in accordance with the present invention when assembled with acatheter;

FIG. 46A is an end view of a distal end of another embodiment of acatheter formed in accordance with the present invention;

FIG. 46B is a partial side elevational view of the distal end of thecatheter shown in FIG. 46A;

FIG. 47 is an end view of another embodiment of a catheter formed inaccordance with the present invention; and

FIG. 48 is an end view of another embodiment of a catheter formed inaccordance with the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Embodiments of the present invention will now be described withreference to the drawings where like numerals correspond to likeelements. Embodiments of the present invention are directed to systemsof the type broadly applicable to numerous medical applications in whichit is desirable to insert one or more steerable or non-steerable imagingdevices, catheters or similar devices into a body lumen or passageway.Specifically, several embodiments of the present invention are generallydirected to medical visualization systems that comprise combinations ofdisposable and resuable components, such as catheters, functionalhandles, hubs, optical devices, etc.

Other embodiments of the present invention are generally directed tofeatures and aspects of an in-vivo visualization system that comprises acatheter having a working channel through which a catheter havingviewing capabilities is routed. As will be described in detail below,the catheter may obtain viewing capabilities by being constructed as avision catheter or by having a fiberscope or other viewing deviceselectively routed through one of its channels. The catheter ispreferably of the steerable type so that the distal end of the cathetermay be steered from its proximal end as it is advanced within the body.A suitable use for the in-vivo visualization system includes but is notlimited to diagnosis and/or treatment of the duodenum, and particularlythe biliary tree.

Several embodiments of the present invention include medical devices,such as catheters, that incorporate endoscopic features, such asillumination and visualization capabilities, for endoscopically viewinganatomical structures within the body. As such, embodiments of thepresent invention can be used for a variety of different diagnostic andinterventional procedures. Although exemplary embodiments of the presentinvention will be described hereinafter with reference to duodenoscopes,it will be appreciated that aspects of the present invention have wideapplication, and may be suitable for use with other endoscopes (e.g.,ureteroscopes) or medical devices, such as catheters (e.g., guidecatheters, electrode catheters, angioplasty catheters, etc.).Accordingly, the following descriptions and illustrations herein shouldbe considered illustrative in nature, and thus, not limiting the scopeof the present invention. Additionally, the catheter with visioncapabilities may be utilized alone, as well as in conjunction with aconventional endoscope.

FIG. 1 illustrates an optical catheter system 8 in accordance with oneembodiment of the present invention. The primary components of thesystem 8 include a sterile, single-use, disposable catheter 10, asterile, single-use, disposable hub 20, and a reusable handle 30. In theillustrated embodiment, the hub 20 is integral, i.e., permanently partof, the disposable catheter 10 such that they together define a sterile,single-use, disposable catheter assembly. For example, the hub 20 may bejoined to the catheter 10 with injection molding or adhesive bonding.The catheter assembly defined by the hub 20 and catheter 10 ispreferably packaged in a sterile container or package (not illustrated)prior to use by a physician. In an alternative embodiment, the hub 20 isintegral, i.e., permanently part of, the handle 30. In a furtherembodiment, the hub 20 is not integral with the catheter 10 or thehandle 30, but connects to these items with connectors, such as male andfemale threaded connectors, quick lock connectors, bayonet connectors,snap connectors, or other known connectors.

As is illustrated in FIGS. 2-4, the catheter 10 includes an elongated,preferably cylindrical, body 38 that extends the entire length of thecatheter 10. In one embodiment, the catheter body 38 has an outerdiameter between approximately 5 and 12 French, and preferably betweenapproximately 7 and 10 French. The catheter body 38 may be constructedfrom any suitable material, such as Pebax® (polyether block amides),nylon, polytetrafluoroethylene (PTFE), polyethylene, polyurethane,fluorinated ethylene propylene (FEP), thermoplastic elastomers and thelike, or combinations thereof. The body 38 may be formed of a singlematerial using known techniques in the art, such as extrusion, ormultiple materials by joining multiple extruded sections by heatbonding, adhesive bonding, lamination or other known techniques (e.g.,juxtaposed Nitinol tubes wrapped with an adhesive bonding.

In some applications, e.g. urological, it is desirable that the catheter10 have a varying degree of stiffness from the distal (e.g., renalpelvis) end 18 towards the proximal (e.g., bladder) end 16. The proximalend 16 should be stiff enough for the device to advance in the tract tothe desired location (e.g., in the urinary tract to the renalpelvis/kidney area). The distal end 18 should be soft enough to providea reduction in trauma during insertion but rigid enough to provideadequate support during the procedure and prevent collapse or kinking.According to an embodiment of the present invention for urologicalapplication, the distal portion of the catheter (approximately 1-2inches where the flexing occurs) is made more flexible (i.e., lessstiff) than the remainder of the catheter to allow for steerability ofthe catheter in vivo. Several techniques for constructing a catheterhaving a more flexible distal portion than the remainder of the catheterwill be described in more detail below.

In the embodiment shown in FIG. 1, the catheter 10 includes a proximalportion 42 that extends the majority of the catheter 10 and a distalportion 44. The catheter 10 preferably varies in stiffness between theproximal portion 42 and the distal portion 44. More preferably, theproximal portion 42 is stiffer than the distal portion 44. This allowsthe catheter 10 to be easily advanced without compressing and withminimal twisting while providing deflection capabilities to the distalportion 42 for deflecting the distal end 18. In one embodiment, theproximal portion 42 has a durometer value between 35 and 85 shore D,preferable 60-80 shore D, and the distal portion 44 has a durometervalue between 5 and 55 shore D, preferable 25-40 shore D.

As is illustrated in FIGS. 2 and 3, the catheter 10 may optionallyinclude an inner sheath 56 and/or an outer sleeve 58 that encase thelength of the elongated body 38 or portions thereof. In one embodiment,the sheath 56 is a woven or layered structure, such as a braided designof fine wire or polymeric elements woven or coiled together along thelongitudinal axis of the catheter with conventional catheter braiding(e.g., 2 wires having a diameter ranging from 0.001 to 0.010 incheswound in a 2-over, 2-under helical fashion from the proximal to distalend of the catheter 10). This allows the catheter 10 to be advanced tothe desired anatomical site by increasing the column strength of theassembly while also increasing the torsional rigidity of the catheter.Conventional coiled polymer or braid wire may also be used for thiscomponent with coil wire dimensions ranging in width from 0.002 to 0.120inches and thickness from 0.002 to 0.10 inches. Braided ribbon wire(e.g., 0.002×0.005 inches; 0.003×0.012 inches) may also be used for thesheath 56.

The outer sleeve 58 may comprise of any number of polymer jackets thatare laminated over the first sheath 56. Suitable materials for thesleeve 58 include, but without limitation, polyethylene, such aspolyethylene having a molecular weight in the range of 50,000 to100,000; nylon, such as nylon 12, nylon 4-6, and nylon 6-6; Pebax(polyether block amides); polyurethane; polytetrafluoroethylene (PTFE),particularly fluorinated ethylene propylene (FEP) copolymers; andpolyethylene impregnated with PTFE. The outer sleeve 58 may be used tovary the stiffness of the catheter, if desired, or to provide improvedtorque transfer and/or other desirable catheter properties.Additionally, the sleeve 58 may be used as one convenient method forsecuring a more flexible deflection section to the proximal section, aswill be described in detail below. In one embodiment, as will bedescribed in more detail below, the outer sleeve 58 is coextruded,coated, or otherwise attached once the sheath 56 is applied, to lock thesheath 56 in place and secure it to the catheter body 38, therebyforming a composite catheter.

In several embodiments, the external surface of the catheter, forexample, the outer sleeve 58, can have a hydrophilic coating or asilicone coating to ease the passage of the device in vivo. Such ahydrophilic coating can be, for example, but without limitation, N-VinylPyrrolidone, Poly Vinyl Alcohol, and Poly Vinyl Pyrrolidone. Thehydrophilic coating can be accomplished by coating the device with aprimer, such as Bayhydrol 110 (an anionic dispersion of an aliphaticpolyester urethane resin in water/n-methyl-2pyrrolidone) and thenbonding a primary layer over the primer. The primary layer can be,without limitation, an acrylamide or a polyurethane-based acrylamide.Alliphatic polyether and polyester polyurethanes also can be used aslubricous coatings.

In a further embodiment, the distal portion 44 of the catheter 10 maycontain a preset curve detail that allows a physician to easily accessvarious locations (e.g., the renal pelvis) with minimal manipulation viapassive deflection (i.e., without ex-vivo steering mechanism actuation).In one embodiment, the durometer of the sleeve 58 varies from 35 Shore Dto 85 Shore D (preferably in the region of 70-80 D) at the proximal end16 to 20 Shore D to 55 Shore D (preferably in the region of 30-43 D) atthe distal end 18. Curves of various shapes and geometries may be presetto the distal portion 44 of the catheter 10 as desired. For example,these curves may be pre-baked into the sleeve 58 at an elevatedtemperature below the melting point of the polymer. This pre-baked curvecan vary between 10 and 270 degrees from vertical, depending upon thespecific application of the system 8. To insert the catheter 10, thecurve should be such that when a dilator or stiff guidewire is insertedinto a working channel of the catheter 10 (described below), the curveis straight, while once the dilator or guidewire is removed, the distalportion 44 reverts to the pre-baked curve providing access to a desiredlocation. In one embodiment, the distal portion 44 of the sleeve 58 hasa radiopaque marker band 46 mounted thereon to provide confirmation ofthe location of the distal end 18 via fluoroscopy.

Referring now to FIGS. 2-4, the elongated body 38 of the catheter 10defines a working channel 60 that extends the entire length of thecatheter and allows for the passage of various treatment or diagnosticdevices, such as guide wires, stone retrieval baskets, lasers, biospyforceps etc. The working channel 60 preferably has a diameter sufficientto accept up to a 4 French working device, such as a retrieval basketdevice or biopsy forceps. The elongated body 38 of the catheter 10 mayalso include additional channels 62, for use, e.g., asirrigation/insufflation channels or additional working channels for oneor more of the instruments mentioned above. The channels 62 each extendthe entire length of the catheter 10 and, like the working channel 60,allow the passage of devices, liquids and/or gases to and from thetreatment area. The channels 62 each have a diameter similar to orsmaller than main working channel 60. In one embodiment, the channels 62each have a diameter of about 0.020 inches. The catheter may alsoinclude a channel 64 that extends the entire length of the catheterthrough which a fiberscope, fiber optic cables or other small diameterimaging devices (e.g., 0.25 mm-1.5 mm diameter) can be routed to thedistal end of the catheter 10. It will be appreciated that one or moreof the channels 62 may be eliminated or dimensioned to accommodate thenecessary diameter needed for the working channel 60 and optic lumen.

As is illustrated in FIGS. 2-4, the catheter 10 also includes a pair ofcontrol or steering wires 68 that cause a distal portion 44 of thecatheter 10 to deflect in one or more directions as indicated by thedashed lines in FIG. 1. The steering wires 68 are located on oppositesides of the catheter 10 and slide within grooves 70 in opposite sidesof the elongated body 38. In other embodiments, the steering wires 68may reside in the sheath 56 or outer sleeve 58. In yet anotherembodiment, the steering wires 68 may be routed through dedicatedsteering wire lumens in the catheter. The steering wires 68 extend fromthe distal end 18 of the catheter 10 to the opposing, proximal end 16 ofthe catheter 10, and then through the hub 20. The steering wires 68 maybe attached to the distal end 18 of the catheter 10 in a conventionalmanner, such as adhesive bonding, heat bonding, crimping, laser welding,resistance welding, soldering or other known techniques, at anchorpoints such that movement of the wires causes the distal end to deflectin a controllable manner. In one embodiment, the steering wires 68 areattached via welding or adhesive bonding to a fluoroscopy marker band 46(see FIG. 1) fixedly attached to the distal end. In one embodiment, theband may be held in place via adhesive and/or an outer sleeve, as willbe described in more detail below. The steering wires 68 preferably havesufficient tensile strength and modulus of elasticity that they do notdeform (elongate) during curved deflection. In one embodiment, thesteering wires are made from 304 stainless steel with an 0.008 inchdiameter and have a tensile strength of approximately 325 KPSI. Thesteering wires 68 can be housed in a PTFE thin-walled extrusion (notshown) to aid in lubricity and prevent the catheter 10 from binding upduring deflections, if desired.

In the illustrated embodiment shown in FIG. 1, the steering wires 68terminate in a wire connector 70, which may also be part of the hub 20.The wire connector 70 is a mechanical device that provides a detachable,preferably quick-fit, connection between the steering wires of thecatheter 10 and the controller 74 or handle steering wires (notillustrated) associted with the handle 30. Various types of detachablemechanical connectors, such as joints and linking elements, are capableof forming a connection that allows active deflection of the wires 68via the controller 74 of the handle 30. In the illustrated embodiment,the catheter 10 includes two steering wires 68 that controllably steerthe catheter distal end 18 within one plane. In alternative embodiments,the catheter 10 includes additional wires that allow a user to steer thedistal end 18 in multiple planes. In a further embodiment, the catheter10 only includes one control wire that allows the user to steer thedistal end 18 in one direction. In another embodiment, such as describedbelow, the steering wires 68 are not part of the catheter 10. In such anembodiment, the catheter can be advanced over a guidewire (not shown)pre-placed in the region of interest.

Referring now to FIG. 5, there is shown a cross-sectional view of analternative embodiment of a catheter 510 suitable for use with theoptical catheter system 8. The catheter 510 illustrated in FIG. 5 alsoincludes additional features and inherent functions, as describedfurther below. Unlike the catheter 10, the catheter 510 has one largelumen 512 as opposed to multiple lumens. This is referred to as a “loosetube” configuration. The steering wires 568 run along the inner diameterof the catheter 510 to the distal end and are located within channelsdefined by an internal sleeve or liner 547. The liner 547 has a lowco-efficient of friction to facilitate the passage of working devicesthrough the catheter during surgery. The liner 547 has a wall thicknessfrom 0.0005 to 0.010 inches and is preferably formed from nitinoltubing, a polymer containing a degree of fluoroethylene such as, but notlimited to, FEP, PTFE or PTFE impregnated thermoplastic elastomers likePebax or is formed from a polymer having fluroethylene combined withthermoplastic materials such as polyamides, polyurethane, polyethyleneand block co-polymers thereof. The optical assembly, any workingdevices, and any irrigation tubes pass through the lumen 512 and connectwith the hub as described above and below. In an alternative embodiment,the elongated body 538 of FIGS. 2-4 passes through the lumen 512, wherethe elongated body 538 routes any working devices, the optical assembly,and any irrigation tubes as described above.

The catheter 10 may be constructed in many different ways to achieve thedesired result of a catheter having varying stiffness along its length,a few of which will now be described in more detail. FIG. 12A is alongitudinal cross-section view of one embodiment of a catheter 1210constructed in accordance with aspects of the present invention. As bestshown in FIG. 12A, the catheter 1210 comprises a catheter body 1238 thatis constructed with discrete proximal, deflection, and distal tipsections 1282, 1284, 1288. In this embodiment, the proximal section 1282is stiffer than the deflection section 1284. Each section may beconstructed in any suitable manner, such as extrusion or milling, withany suitable materials, such as polyethylene, nylon, Pebax® (polyetherblock amides), polyurethane, polytetrafluoroethylene (PTFE),thermoplastic elastomers, chosen for the desired application. Thesections 1282, 1284, and 1288 are then coupled together to form anintegral body by encasing the length of the body 1238 or portionsthereof with an outer sleeve 1258. The deflection section may containone or both of section elements 1284 and 1288 to impart the requireddeflection at the distal end to the system. The outer sleeve 1258 maycomprise one of any number of polymer jackets that are laminated,co-extruded, heat shrunk, adhesive bonded, or otherwise attached overthe catheter body 1238. Suitable materials for the sleeve 1258 include,but are not limited to, polyethylene, nylon, Pebax® (polyether blockamides), polyurethane, polytetrafluoroethylene (PTFE), and thermoplasticelastomers to name a few. It will be appreciated that the sections 1282,1284, and 1288 may also be heat bonded or adhesive bonded prior to outersleeve attachment.

The catheter 1210 may optionally include an inner reinforcement sheath1256, for example, a metallic braid, disposed between sections 1282,1284, and 1288 of the elongated body 1238 and the outer sleeve 1258, asbest shown in FIG. 12B. The reinforcement sheath 1256 encases the lengthof the catheter body 1238 or portions thereof. In one embodiment, thereinforcement sheath extends from the proximal end of the catheter bodyto proximal an optional radio opaque band (not shown) at the distal tipsection. The reinforcement sheath increases the kink resistance of thedeflecting section 1284 to ensure that internal lumens remain patentduring bending.

FIG. 13A is a longitudinal cross section view of another embodiment of acatheter 1310 constructed in accordance with aspects of the presentinvention. As best shown in FIG. 13A, the catheter 1310 defines aproximal section 1382, a deflection section 1384, and a distal tipsection 1388. The catheter 1310 comprises a catheter body 1338 and anouter sleeve 1358. The catheter body 1338 is a unitary core that isformed, preferably by extrusion, with one suitable material, such asnylon, Pebax®, PTFE, etc. In one embodiment, the body 1338 is a PTFEextrusion. When assembled, the outer sleeve 1358 encases the length ofthe elongated body 1338 or portions thereof. The outer sleeve 1358comprises a number of polymer jackets 1358A, 1358B, and 1358C that arelaminated, co-extruded, heat shrunk, adhesive bonded, or otherwiseattached over sections 1382, 1384, and 1388 respectively, of thecatheter body 1338. The stiffness value of each jacket is specificallyselected to achieve the desired results, and may vary upon differentcatheter applications.

In one embodiment, the jacket 1358A, which corresponds to the proximalsection 1382, is constructed of a material having a greater stiffnessvalue than the jacket 1358B, which corresponds to the deflection section1384. Suitable materials for the sleeve 1358 include, but are notlimited to, polyethylene, nylon, Pebax® (polyether block amides),polyurethane, polytetrafluoroethylene (PTFE), to name a few. If PTFE ischosen for the body 1338, it may be necessary to etch or otherwiseprepare its outer surface to promote suitable adhesion of the outersleeve 1358.

The catheter 1310 may optionally include an inner reinforcement sheath1356, for example, a metallic braid, disposed between the elongated body1338 and the outer sleeve 1358, as best shown in FIG. 13B. Thereinforcement sheath encases the length of the elongated body 1338 orportions thereof. In one embodiment, the reinforcement sheath extendsfrom the proximal end of the catheter body to proximal an optional radioopaque band (not shown) at the distal tip section. The reinforcementsheath increases the kink resistance of the deflecting section to ensurethat internal lumens remain patent during bending.

FIGS. 14A-14C and 15 illustrate another embodiment of a catheter 1410constructed in accordance with aspects of the present invention. As bestshown in FIG. 14A, the catheter includes a catheter body 1438 having aproximal section 1482, a deflecting section 1484, and a distal tipsection 1488. In one embodiment, the proximal section 1482 isconstructed of a material that is stiffer than the deflecting section1484.

The proximal section 1482 and the deflecting section 1484 may beextrusions constructed from any suitable material, such as polyethylene,nylon, Pebax® (polyether block amides), polyurethane,polytetrafluoroethylene (PTFE), and thermoplastic elastomers, to name afew. In one preferred embodiment for urological application, theproximal section is a multi-lumen, PTFE extrusion approximately 200 to220 cm in length, and the deflecting section 1484 is a multi-lumen,Pebax® extrusion approximately 2 to 10 cm in length. The deflectionsection 1484 may be coupled to the proximal section 1482 via suitableadhesive or joined by other techniques. The distal tip section 1488 maybe coupled to the distal end of the deflection section 1484 via suitableadhesive. The distal tip section 1488 may be constructed of any suitablematerial, such as stainless steel or engineering plastics, including butnot limited to polyethylene, nylon, Pebax® (polyether block amides),polyurethane, polytetrafluoroethylene (PTFE), and thermoplasticelastomers. The catheter body 1438 may also include a radio opaquemarker band 1446 that encircles a portion of the distal tip section1488.

The catheter 1410 (see FIG. 14B) also includes a reinforcement sheath1456 that extends from the proximal end of the catheter to orimmediately proximal of the radio opaque marker band 1446. The sheath1456 may be a woven or layered structure, such as a braided design offine wire or polymeric elements (0.001 inches to 0.010 inches indiameter) woven or coiled together along the longitudinal axis of thecatheter with conventional catheter braiding techniques. This allows thecatheter to be advanced to the desired anatomical site by increasing thecolumn strength of the assembly while also increasing the torsionalrigidity of the catheter. The reinforced catheter body shown in

FIG. 14B is then encased by an outer sleeve 1458 comprising of one ormore sleeve sections 1458A, 1458B, and 1458C, having the same ordifferent stiffness values, as best shown in FIG. 14C, to form thecatheter 1410.

Returning to FIG. 14A, the catheter also includes a plurality ofsteering wires 1468 that extend through grooves or slots formed in thecatheter body from the proximal end of the catheter past the deflectingsection 1484. In one embodiment, the steering wires 1468 terminate atthe radio opaque marker band 1446 to which the steering wires 1468 arejoined by adhesive bonding, laser welding, resistance welding, solderingor other known techniques.

In several embodiments, it is preferable for the steering wires to beencased with a laminate structure 1496 for allowing the steering wires1468 to move freely within or along the catheter body, and thus, makethe mechanics of actuation as smooth as possible. As best shown in FIG.15, the laminate structure 1496 is formed by outer jacket 1497constructed of a thermoplastic polymer, such as polyurethane, Pebax®,thermoplastic elastomer etc. which encases an inner reinforcement member1498, such as a metallic braid (e.g., stainless steel braid having, forexample, a 0.0015″×0.006″ helically wound). Inside the reinforcementmember 1498, is a layer 1499 of a friction reducing material, such asPTFE or FEP tubing, over which the aforementioned layers are formed. Thelaminate structure 1496 begins at the proximal section 1482 and extendsto just proximate the radio opaque marker band 1446, as best shown inFIG. 14A.

As was described above, in several embodiments of the catheter, it isdesirable for the deflection section or distal portion to be configuredto deflect more easily than the proximal section or portion. In oneembodiment, the deflection section or distal portion has a durometervalue less than the proximal section. In other embodiments, theflexibility may be varied gradually (e.g., increasingly) throughout thelength of a catheter tube from its proximal end to its distal end. Inother embodiments, the deflection section may be an articulating joint.For example, the deflection section may include a plurality of segmentsthat allow the distal section to deflect in one or more directions. Forexamples of articulation joints that may be practiced with the presentinvention, please see co-pending U.S. patent application Ser. Nos.10/406,149, 10/811,781, and 10/956,007, the disclosures of which arehereby incorporated by reference.

Other mechanical joints or configurations may be utilized that allow thedistal portion of the catheter to flex or bend in one or more directionsmore easily. Turning now to FIG. 16, there is shown one embodiment of acatheter 1610 formed in accordance with aspects of the presentinvention. FIG. 16 shows a partial view of the distal portion 1646 of acatheter 1610 constructed from a metal or plastic tube with slots 1694cut 180 degrees and spaced an even distance apart to form a deflectingsection. The slots will allow the catheter 1610 to deflect in twodirections or in a single plane at the distal end 1618. The proximalsection of the tube is not slotted and may be used as the non-deflectingportion of the catheter. If preferred, the slotted section may be usedin embodiments discussed above. The slotted section can be useful whenthe catheter profile is not symmetrical or is irregular. It will beappreciated that the slots 1694 can be V-shaped, semi-circle, wave orany preferred configuration.

FIG. 17 illustrates another embodiment of a catheter 1710 having adeflectable distal portion. In this embodiment, the catheter isconstructed from a very flexible plastic extrusion with multiple lumens.The two main lumens, the working channel 1760 and the optical assemblychannel 1762, are reinforced with coils 1796 to minimize out-of planedeflection. As shown in FIG. 17, the center of both lumens and bothcoils lie on the Y-axis to provide less resistance against deflection inthe x-plane. When the steering wires (not shown) are pulled along thedirection of the steering wire slots, the catheter will tend to bendabout the y-axis or in the x plane. The coils 1796 also prevent thelumen from kinking as the catheter deflection radius becomes tighter.The catheter 1710 may further include an outer braid and outer layer, asdescribed in detail above.

FIG. 18 illustrates yet another embodiment of a catheter 1810 having aflexible distal portion 1846. In this embodiment, the multiple lumenextrusion is preferred to be flexible. Slots 1894 are cut on both sidesof the extrusion to assist and bias the catheter 1810 in the preferreddirection of deflection. As was described above, coils 1896 may be usedto support the main lumens, if preferred, but are not required. The coilor coils can be useful if the slot cuts are deep to penetrate the mainlumens. The coils could be used to line the lumens such that the devicesdo not inadvertently get caught against the slots. The catheter mayfurther include a braided sheath and outer sleeve, as described above.

Returning now to FIGS. 1-4, the elongated body 38 of the catheter 10includes a lumen 64 that holds an optical assembly 40 or portionsthereof, as described briefly above. The optical assembly 40 is defined,e.g., by a cylindrical, elongated tubular member 24 and optic bundles32, 34. The optical assembly 40 permits a user of the system 8 to viewobjects at or near the distal end 18 of the catheter 10. In theillustrated embodiment, the distal end 18 of the catheter includes aclear lens or window 22 that sealingly encloses the distal end of thelumen 64 to protect the optic bundles 32, 34 inside the lumen 16. Themember 24 defines multiple lumens 26 that each contain one fiber opticbundle 32, 34. The first fiber optic bundle 32 illuminates the area orobjects to be viewed, while the second fiber optic bundle 34communicates the illuminated image to an eyepiece or ocular lens device36 located at the handle 30 through which a user can view the imagescommunicated via the fiber optic bundle. The handle 30 can also beconfigured to connect to a camera or imaging system such that users cansave images and view them on a display. The fiber optic bundles 32, 34each comprise one or more fiber optics cables, preferably multiple fiberoptical cables, but may also include lenses, rods, mirrors, hollow orsolid light guides, etc. The bundles 32, 34 are attached to the lens 22with a clear adhesive, bond, or other connection, but can also abut thelens or be located adjacent the lens without any attachment. In analternative embodiment, the lens 22 is not attached to the distal end 18of the catheter, but is instead attached directly to the elongatedmember 24 and fiber optic bundles 32, 34.

As will be appreciated, the optical components of the catheter 10 maytake many other forms and configurations. For example, the lumen 64 caninclude one fiber optic bundle for communicating images and one or moresingle illumination fibers that are not fixed relative to each other bythe elongated member 24. That is, the fibers can be freely located inthe lumen 64. Additionally, the elongated member 24 can have more orless lumens 26 that contain more or less fibers and/or bundles forilluminating and/or communicating images. For example, in an alternativeembodiment, a single fiber replaces one or both of the bundles 32, 34.Furthermore, the elongated body 38 need not include the lumen 64. Forexample, one or more optical fibers or bundles of fibers can be moldedin the elongated body 38. Alternatively, the elongated body 38 mayinclude two lumens 64 for receiving separate fiber optic bundles 32 and34, respectively. Possible alternative known configurations for theoptical assembly 40 are described in U.S. Pat. Nos. 4,782,819;4,899,732; 5,456,245; 5,569,161; and 5,938,588, the entire disclosuresof which are hereby incorporated by reference.

In the illustrated embodiment, the tubular optical assembly 40 is partof the disposable catheter assembly defined by the catheter 10 and hub20. Hence, the tubular optical assembly 40 and its fiber optic bundles32, 34 extend from the distal end 18 of the catheter 10 to the opposing,proximal end 16 of the catheter 10, and then through the hub 20. As isillustrated in FIG. 1, the hub 20 includes a fiber optic connector 72 inwhich the fiber optic bundles 32, 34 terminate. The fiber opticconnector 72 is a mechanical device that provides a detachable opticalconnection between the fiber of the optical assembly 40 and the fiber orlens system of the handle 30. Thus, the optical assembly 40 extendscontinuously through the disposable catheter 10 and hub 20, withoutinterruption, to the fiber optic connector 72. In one embodiment, thefiber optic connector 72 is a detachable, simple point-to-pointconnection or splice. In other embodiments, the connector 72 is a morecomplex design having multi-port or other types of optical connections.For example, the connector 72 can be configured to redistribute (combineor split) optical signals, such as with an active or passive fiber opticcouplers, e.g., splitters, optical combiners, X couplers, star couplers,or tree couplers. The fiber optic connecter 72 can also include a microlens, graded-refractive-index (GRIN) rods, beam splitters, and/oroptical mixers, and may twist, fuse, and taper together the fiber opticbundles 32, 34. In other embodiments, such as those described below, theoptical assembly 40 is not part of the disposable catheter 10.

Referring again to FIG. 1, the handle 30 is generally an endoscopichandle that connects to the connectors 70, 72 of the hub 20 such that auser of the system can view images communicated by the fibers of thecatheter 10 and such that a user can controllably steer or deflect thedistal end 18 of the catheter. The handle 30 includes one or more shafts78 that connect to and interact with the fiber optic connector 72 andthe wire connector 70. The handle 30 also includes a controller oractuator 74 by which a user can steer the distal end 18 of the catheter10. In the illustrated embodiment, the handle 30 generally includes apair of steering wires (not illustrated), each of which is associatedwith one of the steering wires 68 of the catheter 10. The wires of thehandle 30 are connected to the controller 74 at one end and areconnected at the other end to the wires 68 via the connector 70. Tosteer the catheter 10, a user actuates the controller 74, which causesthe wires 68 to deflect, which in turn forces the distal end 18 of thecatheter to deflect as illustrated in FIG. 1. In the illustratedembodiment, the controller 74 is a user-operated mechanical slide orrotatable lever that is adapted to pull and release the wires 68connected to the handle 30 by the connector 70. In an alternativeembodiment, the controller 74 may take other forms, such as a rocker armor rotating knob, adapted to pull and release the wires. In anotheralternative embodiment in which the catheter 10 has two or more pairs ofsteering wires, the handle 30 includes additional actuators andcorresponding controls to drive the additional pairs of steering wires.In one embodiment, the handle 30 includes a locking mechanism, such thatwhen a curve is activated by the controller 74, the curve may be lockedin place. The use of wires to steer a tip of a catheter is well-known.Suitable examples are set forth in U.S. Pat. Nos.: 4,899,723; 5,273,535;5,624,397; 5,938,588, 6,544,215, and International Publication No. WO01/78825 A2, the entire disclosures of which are hereby incorporated byreference.

As is described above, the handle 30 includes steering wires and fiberoptics that connect to the steering wires 68 and fiber optic bundles 32,34 of the catheter 10 via the connectors 70, 72. As will be appreciated,the handle 30 may be battery powered or connect to a power supply. Thehandle 30 also includes a light source, or connects to a light source,that illuminates the fiber bundle 32. In addition, the handle 30 has aneyepiece 80 for a user to view an image transmitted by the image bundle34 from the distal end 18.

Referring again to FIG. 1, the hub 20 also includes connectors or ports50 that each communicate with one of the lumens 62 of the catheter 10,as well as a connector or port 52 that communicates with the workingchannel 60. The connectors 50, 52 are preferably integral with the hub20 and thus are disposable with the hub 20 and catheter 10. In theillustrated embodiment, connector 72 is separate from the connector 70and connects to two separate portions, shafts, or projections of thehandle 30. In an alternative embodiment, the connectors 70 and 72 arecombined into a single connector that interfaces with a single portionof the handle 30, such that the optics handle and actuator for steeringare disconnectable as a unit and reusable.

In a further embodiment of a system 608 in which the connectors 670 and672 are separate connectors, such as is illustrated in FIG. 6, theoptical catheter system 608 includes a first handle 630A that steers thecatheter 610 and a second handle or component 630B having the eyepiece680 through which the user can view images communicated by the catheteroptics. In this embodiment, the first handle 630A connects to theconnector 670 and the second handle 630B connects to the connector 672to couple and decouple from the fiber bundle in the catheter 610. Thehandle 630A may be disposable, while the handle 630B is reusable. Thehandle 630B includes a sleeve 682, such as an extrusion over the fiberoptic/illumination fiber component of the handle, to protect fibersterility and prevent damage during the procedure due to the miniaturenature of the fiber.

As will be appreciated from the foregoing, the optical catheter system 8(See FIG. 1) in accordance with one embodiment of the present inventionincludes a sterile, single-use, disposable optical catheter 10, asterile, single-use, disposable hub 20, and a reusable handle 30 forviewing images and steering the catheter. Because the catheter 10 andhub 20 are disposed of after a procedure, delays and costs associatedwith cleaning, sterilizing, and maintaining conventional scopes areavoided.

Set forth below is a description of an exemplary clinical application ofthe optical catheter system 8 according to the invention. The sterilesingle-use catheter 10 and hub 20 are removed from a factory package andthen connected to the reusable handle 30 via the connectors 70 and 72. Aguidewire is advanced into the urinary tract and the catheter 10 with orwithout a dilator is inserted over the guidewire. The guidewire may bewithdrawn. The catheter 10 is then steered with the controller 74 todeflect the distal end 18 to the desired location in the kidney. Theconnectors/ports 50 and 52 are then associated with various workingdevice and irrigation lines, as needed, and the desired treatment and/ordiagnosis are performed. The catheter 10 is then withdrawn anddiscarded.

In an alternative embodiment of the optical catheter system 708illustrated in FIG. 7, the optical assembly 740 is not attached to thedistal end 718 of the catheter and instead extends from the distal end718, through the hub 720, and into the handle 730 without interruption.Additionally, the steering wires 768 extend from the distal end 718,through the hub 720, and into the handle 730 without interruption. Whenfully inserted into the catheter 710, the steering wires 768 each attachto the distal end 718 of the catheter 710 such that movement of thewires causes the distal end 718 to deflect in a controllable manner. Thesteering wires 768 attach to the distal end 718 of the catheter with adetachable connection (not shown), such as a snap or quick lockconnection, that permits the steering wires to be easily detached fromthe distal end 718 after use of the catheter such that the wires can bewithdrawn from the catheter. In this embodiment, the system 708 does notinclude the optical and wire connectors, and the wires 768 and opticalassembly 740 are not disposable. That is, the wires 768 and opticalassembly 740 are part of the reusable handle 730. Hence, in thisembodiment, the lumens and channels of the elongated body receive theelongated wires 768 and elongated optical assembly 740 of the reusablehandle 730 b. The catheter 710 and hub 720 are still disposable.

FIG. 8 illustrates an alternative embodiment of a handle 830 suitablefor use with an optical catheter system 8. The handle 830 includes anoptical portion 686 and a snap-on, slide-on, or clip-on steering portion688. The optical portion 686 is the same as that of the handle 30 (seeFIG. 1), but does not include the features for steering the catheter 10.The steering portion 688 is the same as that of the handle 30 (see FIG.1), but does not include the optical features of the handle 30. Thesteering portion 688 may be disposable or reusable. The optical portion680 is reusable.

In a further embodiment of the optical catheter system 908 illustratedin FIG. 9, the connectors 970 and 972 are not part of the hub 920, butare respectively attached to the optical assembly 940 and the steeringwires 968. The fibers of the optical assembly 940 are not attached tothe distal end 918 of the catheter 910 and, when inserted into catheter,extend from the distal end 918, through the hub 920, and terminate atthe connector 972, which is integral with the optical assembly. Thereusable handle 930 is configured to connect directly to the connector972 of the optical assembly and functions as described above. When fullyinserted into the catheter 910, the steering wires 968 each attach tothe distal end 918 of the catheter 910 such that movement of the wirescauses the distal end 918 to deflect in a controllable manner. Thesteering wires 968 attach to the distal end 918 of the catheter with adetachable connection, such as a snap or quick lock connection, thatpermits the steering wires to be easily detached from the distal end 918after use of the catheter such that the wires can be withdrawn from thecatheter. When inserted into the catheter 910, the wires 968 extend fromthe distal end 918, through the hub 920, and terminate at the connector970, which is integral with the wires. Hence, the wires 968 and theconnector 970 form a control wire assembly. The handle 930 is configuredto connect directly to the connector 970 of the steering wire assemblyand function as described above. In this embodiment, the opticalassembly 940 (and its connector 972) and the wires 968 (and theirconnector 970) are both disposable.

The optical assembly 940 and its connector 972, and the wires 968 andtheir connector 970 may be sterilely packaged separately or incombination with the catheter 910.

FIG. 10 illustrates an additional embodiment of an optical cathetersystem 1008 of the present invention. In this embodiment, the handle1030 for steering the catheter 1010 is integral with the hub 1020 andcatheter 1010, and are together packaged as a single-use, sterile,disposable assembly. The optical handle 1030B and its optical assembly1040 are reusable. Hence, the optical assembly 1040 is received by thehub 1020 and catheter 1010 for use, and then removed therefrom after theprocedure has been performed. The steering wires of the handle 1030A areattached to the distal end 1018 of the catheter 1010 and extend from thedistal end 1018, through the hub 1020, and into the handle 1030A withoutinterruption. In this embodiment, the system 1008 does not include theoptical fiber and steering wire connectors, and the optical assembly1040 is part of, i.e., integral with, the reusable handle 1030B.

FIG. 11 illustrates an additional embodiment of an optical cathetersystem 1108 of the present invention. In this embodiment, the handle1030A for steering the catheter 1110 is integral with the hub 1020 andcatheter 1110, and are together packaged as a single-use, sterile,disposable assembly. The optical handle 1030B is reusable and isconnectable to the disposable optical assembly 1140 via a connector1172. Hence, the optical assembly 1140 is disposable with the integralassembly defined by the handle 1130A, the hub 1120, and catheter 1110,and may also be packaged with these items. The optical assembly 1140 isreceived by the hub 1120 and catheter 1110 for use, removed therefromafter the procedure has been performed, and then discarded with thehandle 1130A, the hub 1120, and catheter 1110. The optical handle 1130Bis reused. The steering wires of the handle 1130A are attached to thedistal end 1118 of the catheter and extend from the distal end 1118,through the hub 1120, and into the handle 1130A without interruption. Inthis embodiment, the system 1108 does not include the steering wireconnector, and the optical assembly 1140 is not integral with thereusable handle 1130B.

FIGS. 19A-19D and 20 illustrate another embodiment of an opticalcatheter system constructed in accordance with the present invention. Asbest shown in FIGS. 19 and 20, the optical catheter system includes asterile, single-use, disposable catheter assembly 1912 (See FIGS.19A-19D) and a resuable optical system 2040 (See FIG. 20). The catheterassembly 1912 includes a handle 1930A and a catheter 1910. The opticalsystem 2040 includes an optical handle 2030B connected to an opticalcable 2042. The optical handle 2030B, in one embodiment, may comprise animage viewing device, such as an ocular 2080, and a coupler 2084.

As best shown in FIG. 19, the catheter 1910 is functionally connected tothe catheter handle 1930B. The catheter 1910 may be any suitablecatheter for use in vivo, such as any one of the catheters described indetail herein. The handle 1930A includes a handle housing 1932 to whicha steering mechanism 1974, optional lock mechanism 1976, and one or moreports 1958, 1960 are operatively connected. In one embodiment, thehandle housing 1932 comprises an upper, proximal section 1934 and alower, distal hub 1936. In the embodiment shown in FIG. 19A, the distalhub 1936 of the handle housing is Y-shaped. The Y-shaped hub 1936includes a distal stem section 1938 to which the proximal end 1912 ofthe catheter 1910 is functionally connected. The Y-shaped hub 1936further includes first and second branch sections 1940 and 1942, thefirst branch section 1940 is connected to the distal end of the housingupper section 1934 while the second branch section 1942 includes anopening through which an interior channel of the catheter, such as theworking channel, may be accessed. The first branch section 1940 may beconnected to the upper section 1934 in such a manner as to permit freeor limited rotation of the Y-shaped hub 1936 with respect to the housingupper section 1934 about a longitudinal axis of the handle 1930A. In oneembodiment, this may be accomplished by a circular flange (not shown)formed at the proximal end of the first branch section and beingcaptured in a cooperating slot (not shown) formed by the distal end ofthe housing upper section.

In one embodiment, handle housing sections are formed by housing halves1934A and 1934B and 1936A and 1936B joined by appropriate removablefasteners, such as screws, or non removable fastening techniques, suchas heat bonding, ultrasonic welding or adhesive bonding. As best shownin FIG. 19A, the housing halves (only 1936B is shown) of the Y-shapedhub 1936 define respective passageways 1948 and 1950 for communicatingwith the remainder of the handle housing 1934 and exterior the handle,respectively. The handle 1930A further includes a bifurcation 1954. Thebifurcation 1954 is preferably insert molded to connect the proximal end1916 of the catheter 1910 and its lumens to the working channel port1958 and optical assembly port 1960. In embodiments where thebifurcation 1954 is insert molded, the catheter steering wires 1968 aresleeved with a PTFE sleeve or a metal sleeve or similar coiled orbraided tube such that molten polymer from the bifurcation process willbond to the sleeve and allow the steering wire within the sleeve to moverespectively therein.

As was described above, the handle housing 1932 includes one or moreports 1958 and 1960 for providing access to the respective channels ofthe catheter 1910. In the embodiment shown, the ports include, but arenot limited to, a working channel port 1958 and an optical assembly port1960. The ports may be defined by any suitable structure. For example,the working channel port 1958 and the optical assembly port 1960 may bedefined by fittings 1962 and 1964, respectively, such as luer fittings,that may be bonded or otherwise secured to the handle housing 1932 whenassembled. In one embodiment, the housing halves may define cooperatingstructure that securely locks the fittings 1962 and 1964 in place whenassembled. The fitting 1962 and 1964 are connected to the appropriatecatheter channels via tubing 1966, as best shown in FIG. 19C. In oneembodiment, the handle 1930A also includes a loop hub 1970interconnected between the optical assembly port 1960 and the tubing1966. The loop hub 1970 has an oversized chamber to allow the opticalcable of the optical system to be deflected to account for the change(shortening) in catheter length when the distal end of the catheter isdeflected by the steering wires 1968.

The catheter handle 1930A may also include a steering mechanism 1974, asbest shown in FIGS. 19A and 19B. The steering mechanism 1974 of thecatheter handle 1930A controls the deflection of the distal end 1918 ofthe catheter 1910. The steering mechanism 1974 may be any known orfuture developed mechanism that is capable of deflecting the distal endof the catheter by selectively pulling one or more steering wires 1968.In the embodiment shown in FIG. 19A and 19B, the steering mechanism 1974includes an activation lever 1980 for effecting 2-way steering of thecatheter distal end in a single plane. By actuating the activation lever1980 in one direction the distal end will deflect in one direction.Turning the activation lever 1980 in the other direction will deflectthe catheter distal end in the opposite direction. It is preferred thatthe catheter distal end will travel in a single plane when sweeping fromone direction to the other. The activation lever 1980 is connected tothe distal end 1918 of the catheter 10 via steering wires 1968 (See FIG.19C), respectively, that extend through the catheter 1910. While amanually actuated steering mechanism for effecting 2-way steering of thedistal end is shown, it will be appreciated that a manually actuatedsteering mechanism that effects 4-way steering may be practiced with andis therefore considered to be within the scope of the present invention.

Referring now to FIGS. 19A-19D, there is shown one embodiment of thesteering mechanism 1974 that may be practiced with the presentinvention. The steering mechanism 1974 includes the activation lever1980 secured for rotation with a pulley 1982. The pulley 1982 isrotatably supported by a boss 1984 integrally formed or otherwisepositioned to extend into the interior of the handle housing 1932 in afixed manner from the housing half 1934B. The pulley 1982 is eitherintegrally formed or keyed for rotation with the activation lever 1980.The proximal ends of one pair of steering wires 1968 are connected toopposite sides of the pulley 1982 in a conventional manner. In theembodiment shown, the steering wires 1968 are placed into respectiveslots 1986 and secured thereto by suitable fasteners, such as set-screws1988. Each set-screw pinches the steering wires 1968 against the pulley1982 to secure it in place. When assembled, the pulley 1982 providescontrol of the distal end 1918 of the catheter 1910 in two directions.In these embodiments, the catheter 1910 is straight in the neutralposition.

It will be appreciated that the steering mechanism may be configuredsuch that the direction of catheter deflection in both directions iseither equal or such that preferential one side deflection is realized(e.g., 180 degree deflection in one direction vs. 90 degree deflectionin the other, etc.). For equal directional deflection, the steeringwires 1968 are of equal length when the catheter is in the neutral(i.e., straight or unbent) position and are attached to the pulley 1982at positions located along an axis of the pulley that is perpendicularto the longitudinal axis of the catheter, as best shown in FIG. 19D. Forunequal angles of deflection, the steering wires are not equivalent inlength and the steering wires are attached to the pulley in otherpositions around the circumference thereof. As will be appreciated, thecatheter side related to the side with the greater steering wiredisplacement will deflect to the greater angle. In embodiments wherethere is only a single deflection of the shaft required, a single pullwire system may be used. The steering wire maybe attached to the pulleyat a position proximal the perpendicular axis of the pulley to maximizethe full swing of the pulley.

In other embodiments, it is also understood that changes could be madeto the design to achieve a mechanical advantage such as to increase thediameter of the pulley for a longer steering wire displacement length.Other configurations that achieve a mechanical advantage may also beused. For example, instead of the steering wires terminating at thepulley, the steering wires may be wrapped around pins positioned on thepulley and then anchored on the handle at points distal the pulley. Inthis case, the steering wires will displace up to twice its normaldistance when compared to the device shown in FIG. 19D. This feature maybe used for larger diameter catheter deflection where longer steeringwire displacement is utilized.

As best shown in FIGS. 19A-19D, the handle 1930A may further include alock mechanism 1976 that functions to lock the catheter 1910 in adesired deflection position or apply tension on the pulley 1982 duringuse. The lock mechanism 1976 includes a tension knob 1988 that isactuatable between a locked position, selectively tensioned positions,and an unlocked position. As best shown in FIG. 19C, the tension knob1988 is threaded onto a thread post 1990 extending from the activationlever 1980. The thread post 1990 extends through the handle housing toallow the tension knob 1990 to be externally mounted. In use, bytightening the tension knob 1990 on the thread post 1990 against thehandle housing 1932 will also bring the activation lever 1980 intocontact with the other handle housing half The user can adjust thetension of the activation lever 1980, as desired, by rotation of thetension knob 1990. Further tightening of the tension knob 1990 willprevent rotation of the activation lever 1980, thereby locking thesteering wires 1968 in place, and in turn, locking the deflectedposition of the catheter 1910.

In accordance with another aspect of the present invention, it may bedesirable to adjust the tensioning of the steering wires after thehandle 1930A has been assembled. Turning now to FIG. 21, there is showna handle having a tension adjustment assembly 2188 accessible fromexterior the housing through a window 2190. The tension adjustmentassembly includes an adjustment screw 2192 cooperatingly engaged with astationary nut 2194. The nut 2194 may be held stationary andnon-rotatable, for example, via molded structure in the handle housing.When assembled, the steering wires 1968 are threaded through thelongitudinal lumen of the adjustment screw 2192. The adjustment screw2192 is designed with teeth on the side of its head portion to allow auser to rotate the screw. Rotation of the screw to advance theadjustment screw 2192 in the direction of arrow A will increase steeringwire tension while rotation of the screw for advancing the screw 2192 inthe direction of arrow B will decrease tension on the steering wires1968. Proper tension will allow quicker response of the steering wire toactuation of the activation lever.

As was discussed briefly above, a small diameter viewing device, such asa fiberscope or other imaging device, may be slidably routed through onechannel (e.g., optical assembly channel) of the catheter 1910 to thedistal end thereof. The viewing device permits the user of the opticalcatheter assembly to view objects at or near the distal end or tip ofthe catheter 1910. Turning now to FIG. 20, there is shown one suitableembodiment of a viewing device or optical assembly 2040 formed inaccordance with aspects of the present invention. The optical assembly2040 includes a fiber optic cable 2072 connected to an optical handle2030B comprising a coupler 2084 and an ocular or eyepiece 2080. Thefiber optic cable 2072 is defined, for example, by one or more opticalfibers or bundles 2032 and 2034 encased by a cylindrical, elongatedtubular sleeve 2076, as best shown in FIG. 22. The outer diameter of thefiber optic cable 2072 is preferably between 0.4 mm and 1.2 mm, althoughother sizes may be used depending on its application and the lumen sizeof the catheter. The tubular sleeve 2076 of the fiber optic cable 2072may be constructed of any suitable material, such as nylon,polyurethane, polyether block amides, just to name a few. Additionally,a metallic hyptotube may be used.

In the illustrated embodiment, as best shown in FIGS. 20 and 22, thefiber optic cable 2072 includes one or more centrally extending coherentimaging fibers or fiber bundles 2034 and one or more circumferentiallyextending illumination fibers or fiber bundles 2032 (which may not becoherent) that generally surround the one or more imaging fibers offiber bundles 2034. The fibers or fiber bundles 2032 and 2034 may beattached to the tubular sleeve 2076 via suitable adhesive. The distalend of the fiber optic cable 2072 includes a distal lens and/or window(not shown) that encloses the distal end to protect the fiber bundles.Alternatively, the optical assembly lumen of the catheter 1910 (See FIG.19) may include a lens or window positioned at its distal end, as wasdescribed in detail above. The distal lens (not shown) also projects theimage from the field of view onto the distal end of the image bundle2034. The image bundle 2034 then transmits the image from the distal endof cable 2072 to the handle 2030B.

The optical assembly 2040 may have a stop collar or sleeve (not shown)to limit movement of the cable 2072 through the optical assembly channelof the catheter and limit the length by which the cable 2072 can extendbeyond the distal end of the catheter 1910. The inner surface of theimaging channel of the catheter may have color markings or othercalibration means to indicate to the user when inserting the cable 2072that the end of the catheter is approaching or has been reached.

The proximal end of the fiber optic cable 2072 is functionally connectedto the coupler 2084 of the handle 2030B. In use, the illumination fibersor fiber bundles 2032 illuminate the area or objects to be viewed, whilethe imaging fibers or fiber bundles 2034 communicates the illuminatedimage to an image viewing device, such as an eyepiece or ocular lensdevice 2080, connected to the coupler 2084 through which a user can viewthe images communicated via the imaging fibers or fiber bundles 2034.The eyepiece 2080 may either be permanently or detachably connected tothe coupler 2084 as shown in FIG. 23A and 23B. In one embodiment, theeyepiece 2080 is detachably connected via a snap fit connector 2098;however, other selectively detachable connectors may be used, such asmale and female threaded connectors, quick lock connectors, bayonetconnectors, to name a few. In this embodiment, the coupler 2084 andcable 2072 can be detached from the eyepiece 2080 after a procedure anddiscarded, while the eyepiece 2080 may be sterilized and reused. Theoptical handle 2030B can also be configured to connect to a camera orimaging system such that users can save images and view them on display.It will be appreciated that the handle 2030B may include other knowncomponents, such as adjustment knobs (not shown), that adjust therelative positioning of the lenses and, thus, adjusts the focus of theimage transmitted through them. The coupler 2084 may also includes alight post 2086 that is connected to the proximal end of theillumination fibers or fiber bundle 2032. The light post 2086 isconfigured to be releasably connected to a light cable for supplyinglight from a light source external the optical assembly 2040 to theillumination fibers or fiber bundle 2032.

In one embodiment, the optical assembly may optionally include acontamination sleeve 2090 for protecting fiber sterility and preventingdamage during the procedure due to the miniature nature of the fiber, asbest shown in FIG. 20. The contamination sleeve 2090 when attached tothe handle extends from the coupler 2084 distally to a section of theoptical cable 2072. The end of the contamination sleeve 2090 terminatesin a distal connector 2092. The distal connector 2092 is configured toconnect to the optical assembly port of the steering handle 1930A,preferably in a sealable manner.

FIG. 24 illustrates another embodiment of a catheter handle 2430constructed in accordance with aspects of the present invention that issuitable for use with the catheter 1910 described above and shown inFIG. 19A. The catheter handle 2430 is substantially similar inconstruction, materials, and operation as the catheter handle 1930Adescribed above and shown in FIGS. 19A-19D, except for the differencesthat will now be described. As best shown in FIG. 24, the distal hubsection 2436 of the handle housing 2432 is not formed as a Y-shapeddistal hub but instead is formed as a tapering cylindrical body. In thisembodiment, both working channel and optical channel ports/luerconnectors 2458-2460 are located at the proximal end of the handlehousing 2432. The connectors 2458 and 2460 are connected incommunication with the respective catheter channels via tubes (notshown). Since the Y-shaped distal hub is not required in thisembodiment, the entire handle housing can be formed by two moldedhousing halves.

FIG. 25 illustrates another embodiment of a catheter handle 2530constructed in accordance with aspects of the present invention that issuitable for use with the catheter 1910 of FIG. 19A. The catheter handle2530 is substantially similar in construction, materials, and operationas the catheter handle described above and shown in FIGS. 19A-19D,except for the differences that will now be described. The catheterhandle 2530 shown in FIG. 25 includes the coupler 2584 and optical cable(not shown) of the optical assembly 2540, the coupler 2584 being slid,snapped into, molded, or otherwise mounted onto or within the handle2530. The components of the optical assembly 2540 are substantiallysimilar in construction, materials, and operation as the components ofthe optical assembly described in FIGS. 20 and 23A, 23B. The light post2588 may be included with the coupler 2584 and may be located in arecessed fitting at the rear of the handle. The working channel port2558 is shown to be side mounted and distal to the activation lever2580. In this embodiment, an ocular (not shown) can be removablyattached to the coupler 2584 for direct viewing if a monitor is notavailable or connected to a monitor if preferred.

FIG. 26 illustrates another embodiment of a catheter handle 2630constructed in accordance with aspects of the present invention that issuitable for use with the catheter 1910 described above and shown inFIG. 19A. The catheter handle 2630 is substantially similar inconstruction, materials, and operation as the catheter handle 1930described above and shown in FIGS. 19A-19D, except for the differencesthat will now be described. As best shown in FIG. 26, the proximalportion 2690 of the handle 2630 has been lengthened such that the handlecan be gripped at either the distal and proximal portions to manipulatethe activation lever 2680 with the thumb or other finger of the user. Itis desirable that sufficient distance exist between the working channelport 2658 and the handle activation lever 2680, so that the user cancomfortable hold the handle without blocking access to the workingchannel port for device feed. The optic assembly hub 2660 is not shownbut can be positioned at the proximal handle end or exiting another sideport at the Y-connector. It will be appreciated that the distal portion2692 can be shortened such that the user uses and holds the proximal endonly. Further, it will be appreciated that additional ports and hubs canbe added, removed or repositioned as desired.

In accordance with another aspect of the present invention, it may bedesirable to the user to provide a way to detect the orientation of theoptical catheter assembly once in vivo. To that end, FIGS. 27A and 27Billustrate one suitable technique for indicating the orientation ofoptical catheter assembly when routed to a site within the patient. Asbest shown in FIG. 27A, an indicator, such as a marker 2764, is placedon the optical cable 2772 of optical assembly 2740 to indicate arelative position, e.g., left side of the optical catheter assembly,when assembled with the catheter to aid the user in orientation andmanipulation of the system. For illustration proposes only, the selectedmarking is shown in FIG. 27A at the distal end of the optic fiber cable2772 and oriented coplanar with the deflection of the catheter distalend as indicated by arrows A-A. In this embodiment, an insert 2770, suchas a metallic insert, is positioned at the distal end of the catheteroptical assembly lumen and may be locked into place when the distal endof the catheter is formed. The insert 2770 is formed with the back endangle cut 2774 oriented to the plane of deflection. The cable sleeve2776 is also configured to have a matching front end angle cut 2778 sothat when meshed, the marker 2764 is oriented to indicate the desiredposition on the image transmitted to the handle. The meshed cuts 2774,2778 also perform an anti-rotation function, that is, the cable 2772 isnot allowed to rotate with respect to the catheter 2710 once meshed, asshown in FIG. 27B. The cable 2772 in this embodiment is made slightlylonger than the catheter 2710 such that the cable deflects slightly inthe loop hub chamber (see FIG. 19C) when mated to create a constantforce against the insert 2770. It will be appreciated that other angles,geometries, keyways, etc. may be used to inhibit rotation of the cablewith respect to the catheter and to orient the indicator in thespecified location.

In operation, when the distal end of the catheter is deflected, thelumen length of the catheter becomes shorter due to the radius of thedeflection curve. The insert 2770 prevents the cable 2772 from extendingany further beyond the catheter distal end. The cable length isdisplaced by means of the fiber deflecting in the loop hub. As thecatheter is straightened, the viscoelastic properties of the cable 2772allows it to relax to the center of the loop hub, while stillmaintaining its position and contact with the insert 2770 at the distalend.

FIG. 28 illustrates a distal end cap 2896 that may be practiced with oneof the catheters described above. A hole 2858 through the cap for theworking channel is the same or larger than the working lumen of thecatheter body. The distal hole 2560 in the cap for the optic fiber issize slightly smaller than the optical cable, establishing a stopmechanism for preventing the cable from exiting the cap yet providing aledge for the cable to constantly abut against. The cable in thisembodiment is made slightly longer than the catheter. The distal cap2876 includes tapered sides 2898 to minimize the cross sectional area ofthe catheter distal end for reducing trauma when advanced in-vivo.

FIG. 29 illustrates another embodiment of a catheter assembly 2912 wherea balloon 2914 is mounted on the catheter 2910 at or near the distal end2918 with an accompanying inflation/deflation port 2962 at the proximalend of the handle. It will be appreciated that different types ofballoons can be used for occlusion, dilatation, anchoring, orstabilizing yet still allow the working channel to remain patent forother uses. Other embodiments may include side ports for injections orsuction. Other features may also be included, including an additionalworking channel as well as elevators, etc. Complex curve deflection canalso be achieved as well as four or multiple way deflections.

FIG. 30 illustrates a cross section of another embodiment of a catheter3010. In this embodiment, it may be desired due to economies ofmanufacture and in the interests of reducing the overall outer diameterof the catheter to split the elements of the optical cable. As bestshown in FIG. 30, there is shown a multi-lumen catheter having separatelumens 3062A and 3062B to house the illumination and image fiber bundles3032 and 3034, respectively. By separating both optic cable componentsin this way, a reduced catheter outer diameter may be realized.

It will be appreciated that the optical catheter system in the variousembodiments described above could be used in other applications, such asa colonoscope, bronchoscope, gastroscope or similar visual device.Additionally, various modifications to the configurations, such as thenumber and dimension of working/optic channels, the length of thecatheter, the materials used in construction, etc., may be made toaccommodate the specific application without departing from the spiritof the invention.

FIG. 31 illustrates one exemplary embodiment of an in-vivo visualizationsystem 3120 constructed in accordance with the present invention. Thevisualization system 3120 includes an endoscope 3124, such as aduodenoscope, to which a steerable catheter assembly 3128 is operativelyconnected. As will be described in more detail below, the steerablecatheter assembly 3128 includes a catheter 3130 and a catheter handle3132. The assembly 3128 may further include a viewing device 2040, suchas a fiberscope (See FIGS. 20 and 23A-23B), or other small imagingdevice that is routed through a channel of the catheter 3130 for viewingobjects at the distal end thereof. While the illustrative embodimentsdescribed below will reference the catheter 3130 and the handle 3132,other suitable catheters, catheter handles, and combinations thereof maybe utilized in the visualization system 3120, such as those cathetersand catheter/optical handles described above with regard to FIGS. 1-30.

In one suitable use, the endoscope 3124 is first navigated down theesophagus of a patient and advanced through the stomach and into theduodenum to the approximate location of the entrance to the common bileduct (also known as the papilla). After positioning the endoscope 3124adjacent the common bile duct entrance, the catheter 3130 of thecatheter assembly 3128 is advanced past the distal end of the endoscope3124 and into the common bile duct entrance. Alternatively, the catheter3130 may be routed prior to endoscope insertion. Once inside the commonbile duct, the fiberscope allows a physician to view tissue in the bileduct, pancreatic duct and/or intrahepatics for diagnosis and/ortreatment.

As best shown in FIG. 31, one suitable embodiment of an endoscope 3124includes an endoscope handle 3140 and an insertion tube 3142. Theinsertion tube 3142 is an elongated flexible body that extends from thedistal end of the endoscope handle 3140. In one embodiment, theinsertion tube 3142 includes an articulation section 3144 disposed atits distal region, and a distal tip 3146. The insertion tube 3142 isconstructed of well known materials, such as polyether block amides(e.g., Pebax®), polyurethane, polytetrafluoroethylene (PTFE), nylon, toname a few.

As best shown in the cross sectional view of FIG. 32, the insertion tube3142 defines a working channel 3150 that extends the entire lengththereof and allows for the passage of various treatment or diagnosticdevices, such as guide wires, biopsy forceps, and the steerable catheter3130 (FIG. 31). The insertion tube 3142 also includes one or more lumensfor the purpose of facilitating the insertion and extraction of fluids,gases, and/or additional medical devices into and out of the body. Forexample, the insertion tube 3142 may include an irrigation and/orinsufflation lumen 3152 and an optional suction lumen 3154. Theinsertion tube 3142 further includes one or more lumens for the purposeof providing endoscopic viewing procedures. For example, the insertiontube 3142 includes one or more lumens 3156 that extend the entire lengthof the catheter and allows for light and optical fiber bundles 3158 and3160 to be routed to the distal end thereof. Alternatively, theinsertion tube 3142 may include one or more LED's and an image sensor,such as a CCD or CMOS, for capturing images at the distal tip andtransmitting them to the endoscope handle 3140. Finally, the insertiontube 3142 includes at least one pair of steering wires 3162A and 3162B,and preferably two pairs of steering wires 3162A, 3162B and 3164A, 3164Bthat are connected at the insertion tube's distal tip and terminatethrough the proximal end of the insertion tube 3142. It will beappreciated that the insertion tube 3142 may include other features notshown but well known in the art.

Returning to FIG. 31, the proximal end of the insertion tube 3142 isfunctionally connected to the distal end of the endoscope handle 3140.At the proximal end of the endoscope handle 3140, there is provided anocular 3166 through which a user can view the images communicated by theoptical fiber bundle 3160 (See FIG. 32), and a light cable 3168 forconnecting to an external source of light. While the endoscope shown inFIG. 31 includes an ocular, the endoscope may be of the electronic type,in which the ocular may be omitted and the images obtained from thedistal end of the endoscope are transmitted to a video processor via thelight cable 3168 or other suitable transmission means, and displayed bya suitable display device, such as a LED monitor. Light from the lightsource can be transmitted to the distal end of the insertion tube 3142via the light fiber bundle 3158. The endoscope handle 3140 also includesa steering mechanism 3170, as shown in the form of control knobs, thatare connected to the steering wires 3162A, 3162B, and 3164A, 3164B (seeFIG. 32) in a conventional manner for deflecting the distal end of theinsertion tube 3142 in one or more directions. The endoscope handle 3140further includes a biopsy port 3172 connected in communication with theworking channel of the insertion tube 3142 for providing access to theworking channel of the insertion tube 3142 from a position exterior theendoscope handle 3140.

The in-vivo visualization system 3120 further includes the steerablecatheter assembly 3128 which will now be described in more detail. Asbest shown in FIGS. 33 and 34, one suitable embodiment of the catheterassembly 3128 includes a catheter handle 3132 from which the catheter3130 extends. The catheter 3130 includes an elongated, preferablycylindrical, catheter body 3176 that extends the entire length of thecatheter 3130 from the catheter proximal end 3178 to the catheter distalend 3180. In one embodiment, the catheter body 3176 has an outerdiameter between approximately 5 and 12 French, and preferably betweenapproximately 7 and 10 French. The catheter body 3176 may be constructedfrom any suitable material, such as Pebax® (polyether block amides),nylon, polytetrafluoroethylene (PTFE), polyethylene, polyurethane,fluorinated ethylene propylene (FEP), thermoplastic elastomers and thelike, or combinations thereof. The body 3176 may be formed of a singlematerial using known techniques in the art, such as extrusion, ormultiple materials by joining multiple extruded sections by heatbonding, adhesive bonding, lamination or other known techniques.According to a preferred embodiment of the present invention, the distalportion of the catheter (approximately 1-2 inches where the flexingoccurs) is made more flexible (i.e., less stiff) than the remainder ofthe catheter.

In the embodiment shown in FIG. 33, the catheter body 3176 includes aproximal section 3182 that extends the majority of the catheter 3130, adeflection section 3184, and a distal tip section 3188. The catheter3130 preferably varies in stiffness between the proximal section and thedistal tip section. More preferably, the proximal section 3182 isstiffer than the deflection section 3184. This allows the catheter to beeasily advanced without compressing and with minimal twisting whileproviding deflection capabilities to the deflection section 3184 fordeflecting the distal end 3180. In one embodiment, the proximal section3182 has a durometer value between 35 and 85 shore D, preferable 60-80shore D, and the deflection section 3184 has a durometer value between 5and 55 shore D, preferable 25-40 shore D.

FIG. 35A is a cross sectional view of one embodiment of the catheterbody 3176. The catheter body 3176 defines a working channel 3192 thatextends the length of the catheter and allows for the passage of varioustreatment or diagnostic devices, such as guide wires, stone retrievalbaskets, lasers, biopsy forceps etc. In one embodiment, the workingchannel 3192 preferably has a diameter sufficient to accept up to a4-French working device, such as biopsy forceps. The catheter body 3176may also include a channel 3194 that extends the entire length of thecatheter through which a fiberscope, fiber optic cable, optical assemblyor other small diameter viewing device (e.g., 0.25 mm-1.5 mm diameter)can be routed to the distal end of the catheter 3130. The catheter body3176 may further include additional channels 3196, 3198 for use, e.g.,as irrigation channels or additional working channels. The channels3196, 3198 each extend the entire length of the catheter and, like theworking channel 3192, allow the passage of devices, liquids and/or gasesto and from the treatment area. These channels 3196, 3198 each have adiameter similar to or smaller than the main working channel, and may besymmetrically positioned to balance the remaining channels duringextrusion. Such positioning of the channels balances out the wallthickness and stiffness in two transverse directions. Finally, thecatheter body 3176 may include one or more steering wire lumens 3200that extend the entire length of the catheter.

Referring to FIGS. 33 and 35A, the catheter 3130 further includes one ormore steering wires 3204 that cause the distal end 3180 of the catheter3130 to deflect in one or more directions. The steering wires 3204 arerouted through a corresponding number of steering wire lumens 3200,extend from the distal end 3180 of the catheter 3130 to the opposing,proximal end 3182 of the catheter 3130, and terminate in a suitablemanner with the steering mechanism, as will be described in detailbelow. The steering wires 3204 may be attached to the distal tip section3188 of the catheter 3130 in a conventional manner, such as adhesivebonding, heat bonding, crimping, laser welding, resistance welding,soldering or other known techniques, at anchor points such that movementof the wires causes the distal end 3180 to deflect in a controllablemanner. In one embodiment, the steering wires 3204 are attached viawelding or adhesive bonding to a fluoroscopy marker band (not shown)fixedly attached to the distal tip section. In one embodiment, the bandmay be held in place via adhesive and/or an outer sleeve, as will bedescribed in more detail below. The steering wires 3204 preferably havesufficient tensile strength and modulus of elasticity that they do notdeform (elongate) during curved deflection. In one embodiment, thesteering wires are made from 304 stainless steel with an 0.008 inchdiameter and have a tensile strength of approximately 325 KPSI. Thesteering wires 3204 can be housed in a PTFE thin-walled extrusion (notshown) to aid in lubricity and prevent the catheter 3130 from binding upduring deflections, if desired.

In the illustrated embodiment shown in FIG. 35A, the catheter 3130includes two pairs of steering wires 3204 that controllably steer thecatheter 3130 in two perpendicular planes. In alternative embodiments,the catheter 3130 includes one pair of steering wires 3204 that allowthe user to steer the distal tip in one plane. In one embodiment, twosteering wires may be provided and are located on opposite sides of thecatheter 3130 and slide within grooves, as opposed to steering wirelumens 3200, formed in the elongated body 3176 or either the sheath orouter sleeve, if included, as will be described in more detail below. Ina further embodiment, the catheter 3130 only includes one steering wire3204 that allows the user to steer the distal tip in one direction. Inanother embodiment, the steering wires may be omitted, and thus, thecatheter 3130 can be of a non-steerable type. In such an embodiment, thecatheter can be advanced over a guidewire (not shown) pre-placed in thebile or pancreatic duct.

In one embodiment, the catheter 3130 may also include an outer sleeve3208 that encases the length of the elongated body 3176, as shown incross section in FIG. 35B, or sections thereof. The outer sleeve 3208may comprise one of any number of polymer jackets that are laminated,co-extruded, heat shrunk, adhesive bonded, or otherwise attached overthe catheter body 3176. Suitable materials for the sleeve 3208 include,but are not limited to, polyethylene, nylon, Pebax® (polyether blockamides), polyurethane, polytetrafluoroethylene (PTFE), thermoplasticelastomers to name a few. The outer sleeve 3208 may be used to vary thestiffness of the catheter, if desired, or to provide improved torquetransfer and/or other desirable catheter properties. Additionally, thesleeve 3208 may be used as one convenient method for securing a moreflexible deflection section to the proximal section, as will bedescribed in detail below. In several embodiments, the external surfaceof the sleeve 3208 may have a hydrophilic coating or a silicon coatingto ease the passage of the device in-vivo, as was described in detailabove with reference to FIGS. 2-4.

In other embodiments, the catheter 3130 may optionally include an innerreinforcement sheath 3210 disposed between the elongated body 3176 andthe outer sleeve 3208. The reinforcement sheath encases the length ofthe elongated body 3176 or portions thereof, as shown in FIG. 35C. Thesheath 3210 may be a woven or layered structure, such as a braideddesign of fine wire or polymeric elements (0.001 inches to 0.010 inchesin diameter) woven or coiled together along the longitudinal axis of thecatheter with conventional catheter braiding techniques. This allows thecatheter to be advanced to the desired anatomical site by increasing thecolumn strength of the assembly while also increasing the torsionalrigidity of the catheter. Conventional coiled polymer or braid wire mayalso be used for this component with coil wire dimensioning ranging inwidth from 0.002 to 0.120 inches and thicknesses from 0.002 to 0.10inches. Braided ribbon wire may also be used for the sheath. In oneembodiment, as will be described in more detail below, the outer sleeve3208 is coextruded, coated, or otherwise attached once the reinforcementlayer 3210 is applied, to lock the reinforcement layer in place andsecure it to the catheter body 3176, thereby forming a compositecatheter.

The catheter may be constructed in many different ways to achieve thedesired result of a catheter having varying stiffness along its length.For example, the catheter may be constructed in a substantially similarmanner to the catheters described above with reference to FIGS. 12A-18.

FIGS. 36A-36C, and 37 illustrates one suitable embodiment of a catheter3630 constructed in accordance with aspects of the present inventionthat may be used with the visualization system described above. As bestshown in FIG. 36A, the catheter includes a catheter body 3676 having aproximal section 3682, a deflecting section 3684, and a distal tipsection 3686. In one embodiment, the proximal section 3682 isconstructed of a material that is stiffer than the deflecting section3684. The proximal section 3682 and the deflecting section 3684 may beextrusions constructed from any suitable material, such as polyethylene,nylon, Pebax® (polyether block amides), polyurethane,polytetrafluoroethylene (PTFE), and thermoplastic elastomers, to name afew. In one preferred embodiment, the proximal section is a multi-lumen,PTFE extrusion approximately 200 to 220 cm in length, and the deflectingsection 3684 is a multi-lumen, Pebax® extrusion approximately 2 to 10 cmin length. The deflection section 3684 may be coupled to the proximalsection 3682 via suitable adhesive or joined by other techniques. Thedistal tip section 3686 may be coupled to the distal end of thedeflection section 3684 via suitable adhesive. The distal tip section3686 may be constructed of any suitable material, such as stainlesssteel or engineering plastics, including but not limited topolyethylene, nylon, Pebax® (polyether block amides), polyurethane,polytetrafluoroethylene (PTFE), and thermoplastic elastomers. Thecatheter body 3676 may also include a radio opaque marker band 3692 thatencircles a portion of the distal tip section 3686.

The catheter 3630 (see FIG. 36B) also includes a reinforcement sheath3688 that extends from the proximal end of the catheter to orimmediately proximal of the radio opaque marker band 3692. The sheath3688 may be a woven or layered structure, such as a braided design offine wire or polymeric elements (0.001 inches to 0.010 inches indiameter) woven or coiled together along the longitudinal axis of thecatheter with conventional catheter braiding techniques. This allows thecatheter to be advanced to the desired anatomical site by increasing thecolumn strength of the assembly while also increasing the torsionalrigidity of the catheter. The reinforced catheter body shown in FIG. 36Bis then encased by an outer sleeve 3690 comprising of one or more sleevesections 3690A, 3690B, and 3690C, having the same or different stiffnessvalues, as best shown in FIG. 36C, to form the catheter 3630.

Returning to FIG. 36A, the catheter also includes a plurality ofsteering wires 3694 that extend through channels of the catheter bodyfrom the proximal end of the catheter past the deflecting section 3684.In one embodiment, the steering wires 3694 terminate at the radio opaquemarker band 3694 to which the steering wires 3694 are joined by adhesivebonding, laser welding, resistance welding, soldering or other knowntechniques. In this embodiment, the catheter body includes openings 3695formed in the outer surface thereof just proximal the radio opaquemarker band 3694 via any suitable method, such as skiving. Theseopenings 3695 communicate with the steering wire channels so that thesteering wires 3694 may exit the extruded catheter body and connect tothe radio opaque marker band 3694, as shown.

In some instances where the catheter body is not extruded or otherwiseconstructed of PTFE or other friction reducing materials, it may bedesirable to encase the steering wires 3694 with a laminate structure3696 for allowing the steering wires 3694 to move freely within thecatheter body, and in particular, the deflecting section 3684, and thus,make the mechanics of actuation as smooth as possible. As best shown inFIG. 37, the laminate structure 3696 is formed by outer jacket 3697constructed of a thermoplastic polymer, such as polyurethane, Pebax®,thermoplastic elastomer etc. which encases an inner reinforcement member3698, such as a metallic braid (e.g., stainless steel braid having, forexample, a 0.0015″×0.006″ helically wound). Inside the reinforcementmember 3698, is a layer 3699 of a friction reducing material, such asPTFE or FEP tubing, over which the aforementioned layers are formed. Inembodiments where the proximal section 3682 is extruded or otherwiseformed with a friction reducing material, the laminate structure 3696begins at the intersection of the proximal section 3682 and thedeflecting section 3684 and extends to just proximate the radio opaquemarker band 3694, as best shown in FIG. 36A.

In accordance with one embodiment of the present invention, themulti-lumen catheters described herein may be extruded using knownmaterials, such as PTFE, Nylon, Pebax®, to name a few. The catheters maybe extruded using mandrels. In several embodiments of the presentinvention, the mandrels may be constructed from suitable materials, suchas stainless steel, stainless steel with PTFE coating, or a phenolplastic, such as Cellcore®. In the embodiment shown in FIG. 35A, themulti-lumen catheter 3130 has eight lumens that include a workingchannel 3192, a fiberscope or viewing device channel 3194, and foursmaller steering wire lumens 3200 spaced 90 degrees apart. To balanceout the wall thicknesses and stiffnesses in the traverse directionsduring extrusion, left and right lumens 3196, 3198 may also be formedusing separate mandrels. These lumens 3196, 3198 may be used for air/gasirrigation and insufflation.

The catheter 3130 shown in FIG. 35B may optionally include an outersleeve 3208. The sleeve may be constructed of suitable materials bycoextrusion, heatshrinking processes, such as reflow, or spray coating.The outer sleeve 3208 may provide additional rigidity, improved torquetransfer, etc. In one embodiment, the outer sleeve may be applied forfacilitating the attachment of a flexible distal section, such as adeflection section, that has a lower durometer value than the remainingcatheter body. In such an embodiment, one suitable material that may beused includes, but is not limited to, Pebax® (polyether block amide). Inother embodiments, the catheter 3130 may include a reinforcement layer3210 or sheath between the catheter body 3176 and the outer sleeve 3208,as best shown in FIG. 35C. The reinforcement may be any known catheterreinforcement structure, such as wire coil or braid. In such asembodiment, the outer sleeve 3208 is coextruded, coated, or otherwiseattached once the reinforcement layer 3210 is applied, to lock thereinforcement layer in place. It will be appreciated that thereinforcement layer 3210 may extend the entire length of the catheter orportions thereof. In one embodiment, the reinforcement layer 3210extends over the deflection section. It will be appreciated that if thebody is extruded from PTFE, its outer surface should be etched orotherwise prepared for appropriate bonding with the outer layer.

In accordance with another embodiment, the catheter may be built upusing a catheter core 3820, an optional reinforcement layer 3824, and anouter sheath or jacket 3826, as best shown in FIGS. 38A-38C. Thecatheter core 3820 is an open-lumen core that is extruded from suitablematerials, such as nylon, PTFE, Pebax®, etc., with the use of mandrels .In this embodiment, the mandrels (not shown) are placed and configuredto produced a plurality of open-lumens 3892, 3894, 3896, 3898, and 3899when extruded. The mandrels may be constructed from metal, Cellcore®, orPTFE. Once the open-lumen core has been extruded, the mandrels are keptin place and the core is either coextruded to add the outer sleeve 3826,as shown in FIG. 38B, or braided and coextruded to add a reinforcementlayer 3824 and an outer sleeve 3826, as shown best in FIG. 38C. As wasdiscussed above, the outer sleeve 3826 may function to lock the braid inplace and/or to facilitate attachment of a distal section, such as adeflection section, having, for example, a lower stiffness value, ifdesired.

The mandrels (not shown) can then be removed after coextrusion. In oneembodiment, the mandrels are constructed of a phenol plastic, such asCellcore®. To remove these mandrels, the mandrels are pulled from one orboth ends. Due to the “necking down” effect inherent to the Cellcore®material, the cross sectional areas of the mandrels decrease when pulledin tension, thereby allowing the mandrels to be removed from thebuilt-up catheter. In one embodiment, this property of Cellcore® may beused to the manufacture's advantage by using such a material for thesteering wire lumen mandrels. However, instead of completely removingthe mandrels from the steering wire lumens, tension forces may beapplied to the steering wire mandrels, and the mandrels may be drawn toa decreased diameter that will be sufficient to function as the steeringwires. Thus, to be used as steering wires, the drawn mandrels are thenconnected to the distal end of the catheter in a conventional manner.While the latter embodiment was described as being coextruded to formthe outer sheath, the outer sheath may be formed on the catheter core bya heat shrink process or spraycoating.

It will be appreciated that not all of the lumens in the latterembodiments need to be formed as open-lumens. Thus, as best shown inFIG. 39A-39C, only the steering wire lumens 3999 are formed asopen-lumens. This will create over sized lumens for the steering wiresand provided the largest possible lumen diameters for the lumens 3992,3994, 3996, and 3998.

As was described above, in several embodiments of the catheter, it isdesirable for the deflection section to be configured to deflect moreeasily than the proximal section. In one embodiment, the deflectionsection has a durometer value less than the proximal section. In otherembodiments, the flexibility may be varied gradually (e.g.,increasingly) throughout the length of a catheter tube from its proximalend to its distal end. In other embodiments, the deflection section maybe an articulating joint. For example, the deflection section mayinclude a plurality of segments that allow the distal section to deflectin one or more directions. For examples of articulation joints that maybe practiced with the present invention, please see co-pending U.S.patent application Ser. Nos. 10/406,149, 10/811,781, and 10/956,007, thedisclosures of which are hereby incorporated by reference. Other methodsthat my be used were described above with reference to FIGS. 16-18.

Returning to FIGS. 33 and 34, the catheter 3130 is functionallyconnected to the catheter handle 3132. The handle 3132 includes a handlehousing 3220 to which a steering mechanism 3224, one or more ports 3226,3228, 3230, and an endoscope attachment device 3234 is operativelyconnected. In one embodiment, the handle housing 3220 is formed by twohousing halves 3220A and 3220B joined by appropriate removablefasteners, such as screws, or non removable fasteners, such as riveting,snaps, heat bonding or adhesive bonding. In the embodiment shown, theproximal end of the catheter 3130 is routed through a strain relieffitting 3238 secured at the distal end of the handle housing 3220 andterminates at a Y connector 3242, as best shown in FIGS. 34 and 45. TheY connector 3242 may be secured to the handle housing 3220 via anysuitable means, such as adhesive bonding. Similarly, the proximal end ofthe catheter 3130 is securely coupled to the Y connector 3242 viasuitable means known in the art, such as adhesive bonding. The Yconnector 3242 includes first and second branch fittings 3244 and 3246that define respective passageways 3248 and 3250 for communicating withthe catheter working channel and the catheter imaging device channel,respectively, through openings 3251 and 3252 located on the outersurface of the catheter, as best shown in FIG. 45.

In embodiments of the present invention, the openings 3251 and 3252 maybe formed by skiving the outer surface of the catheter. This process maybe done manually using known mechanical techniques, or may beaccomplished by laser micro-machining that removes a localized area ofmaterial from the outer surface of the catheter to expose one or morecatheter channels. When assembled, the proximal ends of the catheterchannels are plugged by adhesive or the proximal end of the catheter iscapped to prohibit access to the channels.

As was described above, the handle housing 3220 includes one or moreports 3226, 3228, 3230 for providing access the respective channels ofthe catheter 3130. In the embodiment shown, the ports include, but arenot limited to, a working channel port 3226, an imaging device port3228, and an irrigation/suction port 3230. The ports may be defined byany suitable structure. For example, the working channel port 3226 andthe imaging device port 3228 may be defined by fittings 3254 and 3256,respectively, that may be bonded or otherwise secured to the handlehousing 3220 when assembled. In one embodiment, the housing halves maydefine cooperating structure that securely locks the fittings 3254 and3256 in place when assembled. With regard to the irrigation/suction port3230, a luer style fitting 3258 is preferably used for defining the port3230. The fitting 3258 defines a passageway 3260 for fluidly connectingthe port 3230 with the appropriate catheter channels, as best shown inFIG. 41. The fitting 3258 works in conjunction with a barrel connector3264 that ensconces the catheter 3130. The barrel connector 3264 definesa cavity 3266 that surrounds the perimeter of the catheter 3130 and isfluidly connected to the appropriate catheter channels (irrigationchannels) via inlets 3270. As such, the port 3230 is connected in fluidcommunication with the irrigation channel via passageway 3260 and cavity3266. In one embodiment, the inlets 3270 are formed by skiving the outersurface of the catheter. This process may be done manually using knownmechanical techniques, or may be accomplished by laser micro-machiningthat removes a localized area of material from the outer surface of thecatheter to expose one or more catheter channels. The working channelport 3226 and the imaging device port 3228 are connected incommunication with the branch fittings 3254 and 3256 of the Y connector,respectively, via appropriate tubing 3272, and best shown in FIG. 34.

The catheter handle 3132 also includes a steering mechanism 3224. Thesteering mechanism 3224 of the catheter handle 3132 controls deflectionof the distal end 3180 of the catheter 3130. The steering mechanism 3224may be any known or future developed mechanism that is capable ofdeflecting the distal end of the catheter by selectively pulling thesteering wires. In the embodiment shown in FIGS. 33 and 34, the steeringmechanism 3224 includes two rotatable knobs for effecting 4-way steeringof the catheter distal end in the up/down direction and in theright/left direction. This mechanism 3224 includes an outer knob 3280 tocontrol up/down steering and an inner knob 3284 to control right/leftsteering. Alternatively, the inner knob 3284 may function to controlright/left steering and an outer knob 3280 may function to controlup/down steering. The knobs are connected to the distal end of thecatheter 3130 via the steering wires 3204, respectively, that extendthrough the catheter 3130. While a manually actuated steering mechanismfor effecting 4-way steering of the distal is shown, it will beappreciated that a manually actuated steering mechanism that effects2-way steering may be practiced with and is therefore considered to bewithin the scope of the present invention.

Referring now to FIG. 42, there is shown one embodiment of the steeringmechanism 3224 that may be practiced with the present invention. Thesteering mechanism 3224 includes inner and outer pulleys 3288 and 3290,and control knobs 3280 and 3284. The inner pulley 3288 for left andright bending control is mounted via an inner bore 3294 for rotation ona shaft 3296 integrally formed or otherwise positioned to extend intothe interior of the handle housing 3220 in a fixed manner from thehousing half 3220A. The inner pulley 3288 is integrally formed or keyedfor rotation with one end of an inner rotary shaft 3300. The oppositeend of the inner rotary shaft 3300 extends outside the handle housing3220 to which the control knob 3280 is attached for co-rotation. In oneembodiment, the end 3304 of the inner rotary shaft 3300 is configured tobe keyed with a cooperatingly configured control knob opening. Thecontrol knob 3280 may then be retained thereon via a threaded fastener.The proximal end of one pair of steering wires 3204 are connected toopposite sides of the inner pulley 3288 in a conventional manner.

The outer pulley 3290 for up and down bending control is rotatablyfitted over the inner rotary shaft 3300 for independent rotation withrespect to ,the inner pulley 3288. The outer pulley 3290 is integrallyformed or keyed for rotation with one end of an outer rotary shaft 3310.The outer rotary shaft 3310 is concentrically arranged in a rotationalmanner over the inner rotary shaft 3300. The opposite end of the outerrotary shaft 3310 extends outside the handle housing 3220 to which thecontrol knob 3284 is attached for co-rotation. The rotary shafts 3300,3310 are further supported for rotation within the housing 3220 by aboss 3316 integrally formed or otherwise positioned to extend inwardlyinto the handle housing 3220 from the housing half 3220B. It will beappreciated that other structure may be provided that rotatably supportsthe pulleys 3288, 3290 and shafts 3300, 3310 within the handle housing3220. When assembled, the proximal ends of the second pair of steeringwires 3204 are fixedly connected in a conventional manner to the outerpulley 3290, respectively.

In one embodiment, a thrust plate 3320 is positioned between the innerand outer pulleys 3288, 3290 for isolating rotary motion therebetween.The thrust plate 3320 is restricted from rotation when assembled withinthe housing 3220.

The steering mechanism 3224 may further includes a lock mechanism 3340that functions to lock the catheter 3130 in a desired deflectionposition during use. The lock mechanism 3340 includes a lever 3344 thatis actuatable between a locked position and an unlocked position. In theembodiment shown in FIG. 40, detents 3346 are provided, and may bemolded into the exterior housing half 3220B to index the movementbetween the locked and unlocked positions. A small protuberance (notshown) may be included to signal the user that the lever 3344 haschanged positions.

Referring now to FIGS. 42, 43A, and 43B, the lock mechanism 3340 furtherincludes a lever member 3350 and a pulley member 3354 that are housedwithin the handle housing 3220 when assembled. The lever member 3350includes a throughbore 3358 that is size and configured for receivingthe outer rotary shaft 3310 in a rotationally supporting manner. Thelever member 3350 includes a boss section 3362 that is sized andconfigured to be rotationally supported by the inwardly extending boss3316 when assembled. The boss section 3362 is configured at one end 3364to be keyed for rotation with one end of the lock lever 3344. The levermember 3350 further includes a flange 3366 integrally formed at theother side of the boss section 3362. The end face 3368 of the flange3366 defines a cam profile that annularly extends around the perimeterof the flange 3366. In the embodiment shown, the cam profile is formedby varying the thickness of the flange. The pulley member 3354 includesa boss section 3370 that is sized and configured for receiving the levermember 3350 therein. The pulley member 3354 includes an inwardlyextending flange 3374 that defines a cam profile on the lever memberfacing surface 3378 of the flange 3374. Similar to the lever member3350, the cam profile of the pulley member 3354 is formed by varying thethickness of the flanges as it annularly extends. The inwardly extendingflange 3374 further defines a throughbore 3380 that is sized andconfigured for receiving the outer rotary shaft 3310 in a rotationallysupporting manner. When assembled, the pulley member 33254 is restrictedfrom rotating with respect to the housing 3220 but allowed to linearlytranslate, as will be described in more detail below.

When assembled, the lever member 3350 is inserted within the pulleymember 3354, the cam profiles mate, and the lever 3344 is keyed forrotation to the lever member 3350. The cam profiles on the lever member3350 and the pulley member 3354 are specifically configured to transmita rotary motion of the lever 3344 into translational movement of thepulley member 3354. Thus, when the lever member 3350 rotates by movementof the lever 3344 from the unlocked position to the locked position, thepulley member 3354 moves away from the lever member 3350 in a linearmanner by coaction of the cam profiles. Therefore, the lever member 3350acts like a cam, and the pulley member 3354 acts like a follower toconvert rotary motion of the lever 3344 into linear motion of the pulleymember. The linear movement of the pulley member 3354 causes the innerpulley 3288 to frictionally engage the housing 3220 and the thrust plate3320 while the outer pulley 3290 frictionally engages the thrust plateon one side and the pulley member of the other. The friction presentbetween the engaged surfaces prohibits rotation of the inner and outerpulleys 3288 and 3290, and thus, locks the distal end of the catheter ina deflected position.

To change the deflection of the distal end of the catheter from oneposition to another, the lock lever 3344 is moved from the lockedposition to the unlocked position. This, in turn, rotates the levermember 3350 with respect to the pulley member 3354. Due to theconfiguration of the cam profiles of the lever and pulley members, thepulley member 3354 is capable of moving toward the lever member 3350.This alleviates the friction between the engagement surfaces and allowsthe inner and outer pulleys 3288 and 3290 to rotates by turning thecontrol knobs 3284 and 3280.

In accordance with aspects of the present invention, the catheterassembly 3128 can be mounted directly to the endoscope handle 3140 sothat a single user can manipulate both the endoscope 3124 and thecatheter assembly 3128 using two hands. In the embodiment shown, thecatheter handle 3132 is attached to the endoscope 3124 via the endoscopeattachment device, such as the strap 3234. The strap 3234 can be wrappedaround the endoscope handle 3140, as best shown in FIG. 31. The strap3234 includes a number of notches 3366 into which the head of a housingprojection 3368 is selectively inserted to couple the catheter handle tothe endoscope, as best shown in FIG. 44. The strap 3234 allows thecatheter handle 3132 to rotate around the shaft of the endoscope 3124,if desired. The strap 3234 is positioned such that when used to attachthe handle 3132 to the endoscope 3130, the longitudinal axes of the bothhandles are substantially aligned, as shown best in FIG. 31.Additionally, the strap orientation and the location of the ports on thecatheter handle 3132 allow for manipulation of diagnostic or treatmentdevices and viewing devices through the catheter without interferingwith control and use of the endoscope. As a result of directlyconnecting the catheter assembly 3128 to the endoscope 3124, as shown inFIG. 31, the catheter 3130 creates a loop, known as a service loop,prior to entrance into the biopsy port 3172. In one embodiment, thecatheter may include a proximally located stop sleeve or collar (notshown), which limits the minimum diameter of the service loop and theextension of the catheter 3130 beyond the distal end of the conventionalendoscope. Alternatively, a mark or indicia may be placed on thecatheter 3130 and used to prevent over insertion of the catheter 3130.

In embodiments of the present invention that form a service loop bydirectly connected the catheter handle 3132 to the endoscope 3124, thecatheter 3130 is preferably constructed to be suitably longer thanconventional catheters to compensate for the service loop. In several ofthese embodiments, the catheter handle 3132 is preferable mounted belowthe biopsy port 3172 of the endoscope 3124 and the catheter 3130 ispreferably looped upward and into the biopsy port 3172. In thisconfiguration, the catheter 3130 is accessible and can be gripped by theuser just above the biopsy port for catheter insertion, withdrawal,and/or rotation.

While the embodiment above shows a handle connected below the biopsyport and longitudinally oriented with respect to the catheter, otherconfigurations are possible. For example, the handle can be attached tothe endoscope so that the longitudinal axis of the catheter handle issubstantially transverse to the longitudinal axis of the endoscopehandle. Additionally, the catheter handle may be mounted proximally ordistally of the biopsy port or may be mounted directly on the biopsyport so that the longitudinal axis of the catheter is coaxial with thebiopsy port.

As was discussed briefly above, a small diameter viewing device, such asa fiberscope or other vision device, may be slidably routed through onechannel (e.g., imaging device channel) of the catheter 3130 (FIG. 33) tothe distal end thereof. The viewing device permits the user of thecatheter assembly to view objects at or near the distal end or tip ofthe catheter. For a detailed description of one viewing device that maybe utilized by the visualization system, please see the optical assemblydescribed above with regard to FIGS. 20 and 23A-23B. For other examplesof imaging devices that may be practiced with embodiments of the presentinvention, please see the description of the fiber optic cable inco-pending U.S. application Ser. No. 10/914,411, filed Aug. 9, 2004 towhich priority as been claimed, and the guidewire scope described inU.S. Published Patent Application Number 2004/0034311 A1, thedisclosures of which are hereby incorporated by reference.

The imaging device 3370 may have a stop collar or sleeve (not shown) tolimit movement of the cable 3372 through the imaging device channel ofthe endoscope and limit the length by which the cable 3372 can extendbeyond the distal tip of the catheter 3130. The inner surface of theimaging channel of the catheter may have color markings or othercalibration means to indicate to the user when inserting the cable 3372that the end of the catheter is approaching or has been reached.

One suitable method of operation of the in-vivo visualization system3120 will now be described in detail with reference to theaforementioned FIGURES. The insertion tube 3142 of the endoscope 3124 isfirst navigated down the esophagus of a patient under endoscopevisualization. The insertion tube 3142 of the endoscope 3124 is advancedthrough the stomach and into the duodenum at the bottom of the stomach.The biliary tree comprises the cystic duct from the gall bladder, thehepatic duct from the liver and the pancreatic duct from the pancreas.Each of these ducts joins into the common bile duct. The common bileduct intersects with the duodenum a slight distance below the stomach.The papilla controls the size of the opening at the intersection betweenthe bile duct and duodenum.

The papilla must be crossed in order to reach the common bile duct toperform a biliary procedure. The insertion tube 3142 of the endoscope3124 is navigated under direct visualization so that the exit port ofthe working channel 3150 is directly across from the papilla or so thatthe port is slightly below the papilla. After positioning the distal endof the insertion tube 3142 in the proper position, the catheter 3130with the imaging device 3370 is advanced through the working channel3150 the endoscope 3124 such that the distal end of the catheter 3130emerges from the endoscope and cannulates the papilla. The endoscope3124 provides viewing of the catheter 3130 as it emerges from theendoscope 3124 and is advanced to enter the papilla. After cannulatingthe papilla, the catheter 3130 may be advanced into the common bileduct. Once advanced into the common bile duct, the fiber optic cable3372 of the viewing device 3370 located within the catheter 3130 allowsa physician to view tissue in the bile duct for diagnosis and/ortreatment.

Alternatively, once the insertion tube 3142 of the endoscope 3124 is inplace next to the papilla, a conventional guidewire and sphinctertomemay be advanced together through the endoscope and through the papillato enter the common bile duct and pancreatic duct. It may be necessaryfor the physician to use the sphinctertome to enlarge the papilla. Thesphinctertome may then be removed from the patient while leaving theconventional guidewire in place. The catheter 3130 and the fiber opticcable 3372 of the viewing device 3370 may then be advanced together overthe conventional guidewire through the papilla and into the common bileduct. Once inside the common bile duct, the fiber optic cable 3372 ofthe viewing device 3370 allows a physician to view tissue in the bileduct for diagnosis and/or treatment.

It will be appreciated that the selection of materials and use ofinsertable and removable optics in the catheter allow for the catheterto be constructed as a single use device. Once the procedure isperformed, the optics can be removed and sterilized for reuse while thecatheter may be removed from the endoscope and discarded.

While the steerable catheter assembly 3128 has been described above foruse with an endoscope, it will be appreciated that the catheter assemblymay be used with other devices, or may be used as a stand-alone deviceor in conjuction with the viewing device 3370.

FIGS. 46A-46B illustrates the distal end of an alternative embodiment ofa catheter 4630 formed in accordance with aspects of the presentinvention. In this embodiment, the catheter 4630 has a multi-lumendesign with one or more (shown as three) steering wire lumens 4640around its perimeter. Steering wires (not shown) extend from theproximal end of the catheter to the distal region of the catheter andterminate in an anchored connection at or near the distal end thereof.Deflection of the distal end of the catheter may be effected by thesteering wires in a manner well known in the art. The catheter 4630includes other lumens, for example, a guide wire lumen 4660, a workingchannel lumen 4662, and a fiberscope or other viewing device lumen 4664.As shown, the guide wire lumen 4660 is offset from the longitudinal axisof the catheter.

In use, the tip of the catheter is advanced beyond the end of theendoscope and is steered in the direction of the papilla. The guide wireis then advanced through the papilla and the catheter is advanced tocannulate the papilla. Once in the biliary tree, and with visualizationprovided via the fiberscope or other viewing device, the guide wire isadvanced again and steered to the target site. The catheter is once moreadvanced over the guide wire and positioned for use of the accessoryinstruments at the therapy site while simultaneously viewing such sitewith the fiberscope.

In an alternative embodiment, instead of extruding the catheter body, acatheter 4730 may be constructed with an outer sheath 4758 encasing abundle 4770 of smaller diameter tubes, as best shown in FIG. 47. Eachtube of the bundle of tubes may be formed using any known technique,such as extrusion. Each tube extends the length of the catheter and maybe used for a specific function, such as steering wire lumens, deviceworking channel, optic channel, fluid or air infusion channel, orsection channel, etc. Each tube is preferably separately constructedwith materials specifically selected to maximize performance, lubricity,flexibility, and/or other desirable characteristics. When assembled, oneor more steering wires 4774 are routed through a corresponding number ofsteering tubes 4776 of the catheter. The steering wires 4774 may beconnected to the distal end of the catheter via adhesive, heat bonding,crimping, or other known techniques. In one embodiment, the steeringwires may be attached to a radio opaque marker band 4780 for use influoroscopy.

Alternatively, as best shown in FIG. 48, a catheter 4830 may be formedfrom a steering sheath 4854, such as a steering guide catheter ofappropriate dimensions, by filling the central longitudinal lumen 4856with a bundle of tubes. The steering sheath 4854 typically includes anouter sleeve or jacket 4858 with an internal sleeve or liner 4862. Thesteering wires 4874 typically run along the inner surface of thecatheter to the distal end and are located within channels 4877 definedby the internal sleeve or liner 4862. The liner preferably has a lowcoefficient of friction to facilitate the passage of wires, and may beformed from a polymer containing PTFE or PTFE impregnated thermoplasticelastomers, or may be constructed of thermoplastic materials, such aspolyamides, polyurethane, polyethylene, and block copolymers thereof

The principles, preferred embodiments, and modes of operation of thepresent invention have been described in the foregoing description.However, the invention which is intended to be protected is not to beconstrued as limited to the particular embodiments disclosed. Further,the embodiments described herein are to be regarded as illustrativerather than restrictive. Variations and changes may be made by others,and equivalents employed, without departing from the spirit of thepresent invention. Accordingly, it is expressly intended that all suchvariations, changes, and equivalents which fall within the spirit andscope of the present invention.

1-33. (canceled)
 34. A catheter system, comprising: a shaft assemblyconfigured for insertion into a body of a subject, the shaft assemblyincluding: a proximal end, a distal end, a central longitudinal axis,and a plurality of lumens extending through the shaft assembly betweenthe proximal and distal ends, the plurality of lumens including: aworking lumen having a central longitudinal axis, wherein the centrallongitudinal axis of the working lumen is offset from the centrallongitudinal axis of the shaft assembly, an imaging lumen containing animage transmitter, the imaging lumen having a central longitudinal axisoffset from the central longitudinal axis of the shaft assembly, whereina single plane intersects the central longitudinal axes of the shaftassembly, the working lumen, and the imaging lumen, and a plurality offluid lumens configured to convey fluid, the plurality of fluid lumensincluding: a first fluid lumen having a central longitudinal axis, and asecond fluid lumen having a central longitudinal axis, wherein thecentral longitudinal axis of the first fluid lumen is offset from theplane in a first direction, the central longitudinal axis of the secondfluid lumen is offset from the plane in a second direction, and thefirst direction is opposite the second direction.
 35. The cathetersystem of claim 34, wherein a cross-sectional area of the imaging lumenis greater than a cross-sectional area of the first fluid lumen.
 36. Thecatheter system of claim 35, wherein the cross-sectional area of theimaging lumen is greater than a cross-sectional area of the second fluidlumen.
 37. The catheter system of claim 35, wherein a cross-sectionalarea of the working lumen is greater than the cross-sectional area ofthe imaging lumen.
 38. The catheter system of claim 34, wherein theworking lumen and the imaging lumen are differently sized.
 39. Thecatheter system of claim 38, wherein the imaging lumen and at least oneof the first fluid lumen and the second fluid lumen are differentlysized.
 40. The catheter system of claim 34, wherein the plane is a firstplane, and the central longitudinal axes of the first fluid lumen andthe second fluid lumen lie in a second plane perpendicular to the firstplane.
 41. The catheter system of claim 34, wherein the second plane isoffset from the central longitudinal axis of the shaft assembly.
 42. Acatheter system, comprising: a shaft assembly configured for insertioninto a body of a subject, the shaft assembly including: a proximal end,a distal end, and a plurality of lumens extending through the shaftassembly between the proximal and distal ends, the plurality of lumensincluding: an imaging lumen containing an image transmitter, and anillumination lumen containing an illumination light transmitter; ahandle assembly, wherein the handle assembly is enlarged relative to theshaft assembly to remain outside of the body of the subject for grippingby a user, the handle assembly including: a proximal end, and a distalend coupled to the proximal end of the shaft assembly; and connectorsfixed to the proximal end of the handle assembly, wherein the image andillumination light transmitters are operatively coupled to theconnectors such that image transmissions and illumination lighttransmissions flow between the image and illumination light transmittersand the connectors, and the connectors are configured to couple thehandle assembly to external imaging and illumination devices.
 43. Thecatheter system of claim 42, wherein the connectors include a firstconnector coupled to the image transmitter, the first connector isfixedly coupled to the handle assembly, and the first connector extendsout of the handle assembly.
 44. The catheter system of claim 43, whereinthe connectors include a second connector coupled to the illuminationlight transmitter, the second connector is fixedly coupled to the handleassembly, and the second connector extends out of the handle assembly.45. The catheter system of claim 44, wherein the first connector isoffset from the second connector.
 46. The catheter system of claim 42,wherein the image and illumination light transmitters are fixed withinthe shaft assembly such that the image and illumination lighttransmitters are not removable from the shaft assembly during use.
 47. Acatheter system, comprising: a shaft assembly configured for insertioninto a body of a subject, the shaft assembly including: a proximal end,a distal end, a central longitudinal axis, and a plurality of lumensextending through the shaft assembly between the proximal and distalends, the plurality of lumens including: a working lumen having acentral longitudinal axis, wherein the central longitudinal axis of theworking lumen is offset from the central longitudinal axis of the shaftassembly, an imaging lumen containing an image transmitter, wherein theimaging lumen is offset from the central longitudinal axis of the shaftassembly, and a plurality of fluid lumens configured to convey fluid,the plurality of fluid lumens including: a first fluid lumen, and asecond fluid lumen, wherein the first and second fluid lumens are offsetfrom the central longitudinal axis of the shaft assembly, and theimaging lumen is between the first and second fluid lumens.
 48. Thecatheter system of claim 47, wherein the plurality of lumens furtherinclude an illumination lumen containing an illumination lighttransmitter.
 49. The catheter system of claim 48, wherein theillumination lumen is between the imaging lumen and the first fluidlumen.
 50. The catheter system of claim 48, wherein a cross-sectionalarea of the illumination lumen is less than each of a cross-sectionalarea of the first fluid lumen, a cross-sectional area of the secondfluid lumen, and a cross-sectional area of the working lumen.
 51. Thecatheter system of claim 48, further including: a handle assembly,wherein the handle assembly is enlarged relative to the shaft assemblyto remain outside of the body of the subject for gripping by a user, thehandle assembly including: a proximal end, and a distal end coupled tothe proximal end of the shaft assembly; and connectors fixed to theproximal end of the handle assembly, wherein the image and illuminationlight transmitters are operatively coupled to the connectors such thatimage transmissions and illumination light transmissions flow betweenthe image and illumination light transmitters and the connectors, andthe connectors are configured to couple the handle assembly to externalimaging and illumination devices.
 52. The catheter system of claim 47,wherein the imaging lumen has a central longitudinal axis, and thecentral longitudinal axes of the working lumen, imaging lumen, and shaftassembly lie in a plane.
 53. The catheter system of claim 52, whereinthe first fluid lumen is offset from the plane in a first direction, thesecond fluid lumen is offset from the plane in a second direction, andthe first direction is directly opposite the second direction.